1. No category

August 2012 | Vol. 4, Number 8
Supreme Court’s Health Care Ruling Ushers in
Host of Reforms Affecting Kidney Care
Inside By Eric Seaborg
T
he Supreme Court ruling
upholding the constitutionality
of the Affordable Care Act (ACA)
gave the green light to a host of reforms
that will affect the practice of kidney care.
The possibility remains that Repub-
licans will win the presidency as well as
control of both houses of Congress with
majorities large enough to repeal the
law or hamper its implementation. But
in the absence of that large political
turnabout, some changes that could
affect nephrology practice include a
large expansion of insurance coverage, a system needing adjustments
to provide services to more people,
and the output of new programs for research on
care quality.
The main goal of
the ACA was to increase the number
of Americans covered by health insurance, and the
latest projections of
the nonpartisan Congressional Budget Office are
that an additional 30 to 33 million people will have health insurance by 2016,
an increase from today’s 82 percent to 92
percent of the population under Medicare
age. One big driver of the growth in coverage is a planned expansion of Medicaid
eligibility, but the portion of the court
ruling that allows states to opt out of the
expansion could have a big effect on these
numbers (see sidebars). But in any scenario, millions more people should obtain
coverage.
An underlying theme of the reform is
that this increased coverage should translate into earlier and better care. “Increasing access to primary care can only be a
good thing in terms of preventing and
slowing the progression of kidney disease,”
said Rachel Shaffer, manager of policy and
government affairs at the American Society of Nephrology.
Early treatment in the primary-care
environment of two common causes of
kidney failure, hypertension and diabetes, could prevent or delay the need for
many patients to see a nephrologist, said
Thomas Hostetter, MD, chair of ASN’s
public policy board: “If more people have
coverage, we would not be in the position
Continued on page 2
Delayed Graft Function: Increasingly Common, and
Increasingly Expensive
D
elayed graft function (DGF)
is a growing problem in kidney donation, given that donor kidneys increasingly come from
older and more health-compromised
individuals. Among other effects, the
impact is felt on the hospital’s bottom
line. The complex picture of DGF in
renal transplantation was the focus
of a discussion among experts in a
“Transplantation in Depth” panel at
the American Transplant Congress in
Boston.
The gap between supply and demand for kidneys is growing, with
92,000 patients on the waiting list in
the United States alone. The shortage
of organs and the lengthening of wait
times have led to considerable reliance
on expanded-criteria donor (ECD)
kidneys, defined as those from donors
over age 60, or between 50 and 59
with either a history of hypertension,
elevated creatinine, or death resulting
from cerebrovascular disease. “These
donors are associated with higher risk
of DGF,” said Norberto Perico, MD,
of the Mario Negri Institute for Pharmacological Research in Bergamo, Italy, “and may account for the increase
in DGF in the last 2 decades.”
The incidence of DGF in ECD
kidneys is between 5 percent and 50
Continued on page 4
3 States and Health
Care Ruling
Medicaid ruling farreaching; how are
states preparing?
6
Findings: American
Transplant
Congress
Protecting the
kidney during liver
transplantation,
determining health
consequences for living
kidney donors, debating
regulation versus
autonomy in transplant
programs
12 Peritoneal Dialysis
Organizing a
successful program,
enhancing education,
empowering patients,
and understanding
regulatory and
reimbursement
changes
24 Policy Update
CMS proposes new
dialysis bundled
payment rate, new and
expanded clinical and
reporting measures,
plus criteria for
removing or replacing
measures
2
| ASN Kidney News | August 2012
Health Care
Ruling
Continued from page 1
where we’ve often been, where people arrive with very advanced kidney disease
having had little if any prior care.”
Another reform provision that could
prove relevant is that insurers will not be
able to deny coverage based on preexisting
conditions, making it easier for patients
with incipient or more advanced kidney disease to obtain coverage. The ACA
also eliminates annual and lifetime caps
on covered expenses, which could help
chronic kidney disease patients who do
not progress to Medicare coverage or family members on their policy.
The expansion of coverage will be driven by incentives and subsidies for buying
health insurance, penalties for not buying it, and an expansion of Medicaid and
the Children’s Health Insurance Program.
Individuals and small employers will be
provided easier access to health insurance
through the establishment of health insurance exchanges set up in each state. So
far, 17 states and the District of Columbia
have taken the first steps toward establishing exchanges, which are scheduled to
come on line in 2014. Some governors
have said that their states will not participate in these exchanges, but residents of
those states will have access to a multi-state
exchange set up by the U.S. Department
of Health and Human Services.
To be sold on the exchanges, policies will
need to meet defined standards, including
what the ACA calls “essential benefits packages.” The packages will be defined mostly
by the states where they are offered based
largely on the customary policies already
available, but they will also have to meet
standards for deductibles and out-of-pocket
costs. The federal government will also have
a role in setting standards, and one of the
key questions to be answered in coming
months is what essential benefits packages
will include in terms of kidney care.
These issues include the availability
of immunosuppressive drug coverage for
kidney transplant recipients, the interface
between exchange-based insurance coverage and Medicare’s end stage renal disease
program, and the treatment of living organ
donors, according to Dolph Chianchiano,
JD, MBA, health policy adviser to the National Kidney Foundation. Chianchiano
said that the U.S. Department of Health
and Human Services (DHHS) is being
slow to weigh in on some of these questions, perhaps to allow states the latitude
to design their own programs.
Coverage of immunosuppressive drugs
would obviously be critical to kidney
transplant patients at the end of the three
years of Medicare coverage. The National
Kidney Foundation and groups like the
American Medical Association have urged
that the essential benefits package be modeled on Medicare Part D, which includes
anti-rejection medications on its list of
protected drug classes. DHHS has not yet
given a specific response on whether kidney transplants and their follow-up care
will have comprehensive coverage although
it acknowledges that transplant benefits are
typically provided in private insurance.
Another issue is whether patients who
receive end stage renal disease treatment
will have to enroll in Medicare, or whether
they can stay on their private insurance for
their care. In a Federal Register posting,
DHHS said that individuals would not
automatically lose their private coverage if
they are eligible for Medicare coverage. In
addition, new end stage renal disease patients can remain in their small group employer health insurance available through
the exchanges, rather than transfer to
Medicare, for the first 30 months of kidney
replacement therapy, Chianchiano said.
Living kidney donors do not have a preexisting condition, “but insurance companies on occasion have acted as if they [do],”
Chianchiano said. “One would assume
that if you cannot discriminate against an
individual because of a preexisting condition, an insurer cannot discriminate
against someone because they have been
a living organ donor.” This protection has
not been spelled out explicitly, however.
An influx of millions of new patients
will pose a challenge to a health care system already facing physician shortages,
said Atul Grover, MD, PhD, chief public
policy officer of the Association of American Medical Colleges (AAMC), particularly the teaching hospitals that his organization represents.
A key concern of the AAMC is whether
the Medicaid expansion will take place as
planned. Hospitals are facing cuts in Medicare and disproportionate share payments
written into the ACA, cuts they could accept based on the assumption that with
more people being covered, more patients
would be able to pay for the services they
receive. If some governors make good
on their threats to not expand Medicaid,
that will throw a monkey wrench into the
whole formula. Grover looked to the experience of Massachusetts, which passed
its reform aimed at universal coverage in
2006, for clues about the future.
“They had a very small percent uninsured, 2 or 3 percent, [yet] a lot of those
who remained uninsured ended up in our
teaching hospitals, so they had to go back
and tweak the formulas for how they appropriated some of the [disproportionate
share] money in those cases,” Grover said.
Looming physician shortages
The AAMC’s other big concern is that it
had been projecting looming shortages of
physicians and other health care professionals even before the ACA passed. “If you
add to that 32 million people potentially
gaining new insurance, you are really accelerating those shortages because people
are going to end up in the system where
maybe they weren’t going to be before,”
Grover said.
Grover noted that in Massachusetts
patients have not experienced difficulty
obtaining care: “In primary care in particular, they have figured out how to use
other health care professionals, nurse
practitioners and physician’s assistants, to
improve access.” But demand has risen:
a study by a Boston University School of
Medicine professor found that inpatient
procedures increased among lower- and
medium-income Hispanics and whites after the health reform law went into effect.
Hispanic patients underwent 22 percent
more elective surgeries, including knee and
hip replacements.
Grover questioned whether a system in
which Medicare has not supported its share
of the cost of training physicians at teaching hospitals could adjust to more patients
nationwide: “We have advocated a modest
expansion of residency training to try and
close a third of the gap between now and
2020 or 2025, in hopes that some of the
delivery system reforms, some of the focus
on prevention, can actually slow down the
increase in demands for physicians’ care.”
Patient outcome research
The kidney community also has its eyes
on a pair of research centers established by
the ACA. The Patient-Centered Outcomes
Research Institute (PCORI) is a nonprofit
organization governed by a board drawn
from the public and private sectors and
appointed by the head of the Government Accountability Office. Created to
back comparative effectiveness research,
particularly kinds that are difficult to find
funding for, PCORI’s research will extend
to all disciplines, but could have particular
benefits for nephology.
“We are the first to admit that there is
insufficient hard data for lots of things that
we do for patients,” Hostetter said. “There
are some things that we understand well
for the general population, but we get different outcomes if we use that approach
with people with end stage renal disease.”
The Centers for Medicare and Medicaid Innovation is another new creation,
within the Centers for Medicare and Medicaid Services, with a mission of finding
new payment and delivery methods that
improve care and health while lowering costs—including looking at ways to
improve kidney care. As a part of this effort, DHHS has recognized 154 accountable care organizations (ACOs), groups
of doctors and other providers who work
together to coordinate care for Medicare
recipients.
Hostetter said that ASN has weighed
in with recommendations on future directions because kidney care is particularly well-suited for refinement in this
sort of venue: “People with most kinds of
early kidney disease can be cared for by
primary-care providers, sometimes with
consultation to a nephrologist. But there
is a stage in chronic kidney disease where
it’s important that there be integrated care,
then there is a stage where it’s important
that a nephrologist do essentially all of the
care for the kidney portion of a person’s illness.” Research could certainly contribute
to better integrating these states.
By upholding the Affordable Care Act,
the Supreme Court allowed these kinds of
efforts to continue. Many supporters of
the ACA’s goals in the health care community acknowledged that the law has its
flaws, but echoed the hope of American
College of Physicians president David L.
Bronson, MD, that the debate could move
away from whether or not to repeal the
law in order to focus on “preserving all of
the good things that it does while making
needed improvements.”
The Individual Mandate
Perhaps the most controversial provision of the Affordable Care Act is the socalled individual mandate that individuals must either buy health insurance or
pay a penalty. Chief Justice John Roberts led the Supreme Court in ruling that
the mandate is constitutional because it is a tax.
The penalty is $95 or 1 percent of income in 2014, $325 or 2 percent of
income in 2015, and $695 or 2.5 percent of income in 2016 (but no more
than the cost of an average basic plan). These penalties are generally much
less than the cost of insurance.
But the experience in Massachusetts—the ACA was largely modeled on
that state’s 2006 health care reform law—has been that the penalties do
seem to be effective at getting people on the insurance rolls. That law has
decreased the number of uninsured in the state from 10 percent to 2 percent
of the population.
The Massachusetts law itself is viewed favorably—74 percent of residents
want it to continue versus 9 percent favoring repeal. But the mandate is not
nearly as popular, with 51 percent supporting it, a 2011 poll by the Harvard
School of Public Health and The Boston Globe found.
To encourage people to buy insurance, federal tax credits tied to its cost
compared with income level will be available to people with incomes up to 400
percent of the federal poverty line (about $88,000 for a family of four). Small
businesses with fewer than 25 workers will receive tax credits for up to 50
percent of the premium cost. Employers with 50 or more full-time employees
that do not offer coverage or offer coverage deemed unaffordable will incur
penalties. And employers with more than 200 employees must automatically
enroll new full-time employees in coverage.
The big bargain among stakeholders such as insurers, providers, pharmaceutical companies, and the government was that each could afford to give up
something if enough people were covered with some form of insurance. For
example, insurance companies could afford to waive preexisting conditions if
they knew that a patient could not simply wait until a disorder appeared, then
buy insurance. Similarly, hospitals could accept lower Medicaid reimbursement rates if they took less of a loss from treating uninsured patients who
never paid.
August 2012 | ASN Kidney News |
Medicaid Ruling Could Have Far-Reaching
Effects
How Are Sates Dealing with Health Reform
Fallout?
The Supreme Court ruling making the Affordable Care Act’s intended expansion of Medicaid optional for states is gaining attention as a sleeper issue
that could destabilize some of the compromises struck to gain support for
the law.
“The Roberts Court actually punched a big hole in the law, potentially reducing its historic coverage expansion by as much as a third,” Jeff Goldsmith,
PhD, wrote on The Health Care Blog. Goldsmith is a professor of public health
sciences at the University of Virginia.
Several governors have said that they will not expand Medicaid, even
though, on first look, it appears to be a sweet deal for states. The federal government pays about 60 percent of the costs of the current Medicaid program.
In the expanded version, people with family incomes up to 133 percent of the
federal poverty level would be eligible for Medicaid. The federal government
will cover 100 percent of the cost for these newly eligible people in 2014 and
2015, then pay a declining share to 90 percent from 2020 on.
Even so, at least half a dozen Republican governors running cash-strapped
states have said that they will not expand the program for both ideological
and financial reasons. Medicaid spending is already a huge portion of state
budgets, second only to education, taking 12 percent of state-generated revenues (those not including the federal contribution) in 2009. Some say that
any expansion would come at the expense of taking money from education,
public safety, and other priorities.
The Congressional Budget Office estimates that the expansions of Medicaid and the Children’s Health Insurance Program would provide new coverage
for some 16 to 17 million people, and providers were counting on receiving
at least some payment for treating them. A lack of expansion could continue
to leave millions without coverage.
“Hospitals are watching these developments with mounting alarm,” Goldsmith wrote. “They gave up $155 billion in future Medicare payment reductions to gain 30 million new paying patients, and consented to the reduction
of disproportionate share payments intended to compensate them for their
bad debts and charity care. A cancelled Medicaid expansion would place the
safety net hospitals in those states at serious economic risk.”
Another worry for states is that the health care exchanges the ACA calls
for could lead to their current programs becoming overloaded. In addition to
offering insurance policies, the new exchanges are designed to lower the barriers to Medicaid enrollment. Many people could go to one intending to buy a
policy, but find out they are eligible for Medicaid and enroll online, without the
need for an in-person trip to a state office.
“In some states 5 to 8 percent of the entire population under age 65 are
uninsured despite being Medicaid-eligible. Nationally, this ‘woodwork effect’
could draw out more than 9 million uninsured adults and children,” write Benjamin J. Summers, MD, PhD, and Arnold M. Epstein, MD, both of the Harvard
School of Public Health, in the New England Journal of Medicine. “Millions of
low-income Americans are currently eligible for Medicaid but do not participate because of enrollment barriers, poor retention, or lack of information.”
And if the new enrollees are eligible under the old Medicaid rules, the
federal share of the payment is at the old level, leaving states to pay up to
half their costs.
Waiting on November elections
Opponents continue to work toward a full repeal in Congress, and
presidential candidate Mitt Romney has made repealing the Affordable
Care Act (ACA) one of his primary campaign points. Arizona, Kansas,
Nebraska, and South Dakota continue to hold still or move slowly in
anticipation of the November election.
Opting out of state exchanges and Medicaid expansion
Governors in Florida, Louisiana, Mississippi, Texas, South Carolina,
and Wisconsin have publicly stated that they will not move forward with
state exchanges or the now optional Medicaid expansion. Proponents
of the ACA in these states are expected to push back hard.
Consumers who need insurance in states that do not have their
own exchange will be eligible for participation in the federal health
exchange, and the Department of Health & Human Services (DHHS)
Secretary Kathleen Sebelius has stated that any uninsured who would
have been covered by the Medicaid expansion will not be penalized by
the individual mandate, although details on how this will work remain
limited.
Continuing to move along with state exchanges and Medicaid
expansion
Even as some state governors and policymakers are opposed to the
ACA, many state legislatures and health advocates continue to work on
a basic infrastructure. Fifteen states and the District of Columbia have
either passed legislation or had an executive order signed to establish
exchanges, and 10 states and the District of Columbia have already
begun or are currently working on Medicaid expansion programs. Both
Massachusetts and Utah already have exchanges up and running, and
Massachusetts has already broadened its pool for Medicaid eligibility.
Utah has not yet decided on Medicaid expansion.
Weighing options
In over 20 states, governors and legislators in both political parties
continue to weigh their options between a federal or state exchange
and are waiting for more federal regulations before making any decisions. Many states that have not yet created exchanges are already
out of session for the year, and only one (Michigan) has a bill currently
in session.
States are also scrambling to understand exactly how the Medicaid expansion could help or hurt their tenuous budgets. Although the
federal government will pay 100 percent of the expansion for the first
three years with a gradual decrease to a 90 percent share, even adding a small percentage of costs could be a heavy burden.
Democratic and Republican governors have voiced concern over the
fine print, and both the National Governors Association and the Republican Governors Association have formally asked President Obama and
DHHS to clarify the nuts and bolts of how the expansion will work.
3
4
| ASN Kidney News | August 2012
Delayed Graft
Function
Continued from page 1
Editorial Staff
Editor-in-Chief: Pascale H. Lane, MD, FASN
Executive Editor: Dawn McCoy
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Wendy Weinstock Brown, MD, Jesse Brown VA Medical Center, Northwestern University Feinberg
School of Medicine, University of Illinois at Chicago
Teri Browne, PhD, MSW, University of South Carolina
Stephen Darrow, MD (fellow), University of Minnesota Medical Center
Ira Davis, MD, Baxter Healthcare Corp.
Caroline Jennette, MSW, University of North Carolina Kidney Center
Richard Lafayette, MD, Stanford University Medical Center
Edgar V. Lerma, MD, FASN, University of Illinois – Chicago /Associates in Nephrology, SC
Teri J. Mauch, MD, FASN, University of Utah
Victoria F. Norwood, MD, FASN, University of Virginia
Sheila M. O’Day, MSN, University of Nebraska Medical Center
Matthew A. Sparks, MD, Duke University Hospital
Titte R. Srinivas, MD, Cleveland Clinic
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Copyright© 2012 All rights reserved
percent, depending on the study and
also on the exact definition of DGF,
which in most cases is taken to mean
the need for dialysis within 7 days of
transplantation.
DGF does have important consequences for the success of the graft,
Perico said. A recent metaanalysis of
21 outcome studies suggested that the
risk of graft loss is 41 percent higher
in patients with DGF than in patients
not experiencing DGF.
“But not all expanded-criteria donor kidneys are equal,” Perico said.
The age is important, but it is far from
the only indicator of organ quality.
Another factor at work is the duration
of cold ischemia time. In a 2011 study
of more than 9000 donor kidneys,
an increase in cold ischemia time increased the risk of DGF after multiple
other characteristics were controlled
for. But in this case, there was no difference in graft survival at 96 months,
highlighting the complexity of the impact of DGF on outcomes.
In any event, Perico said, “We need
to look for strategies to maximize
chances of success with ECD kidneys.”
He suggested that one strategy may be
to use biopsy to match donors with
patients for “nephron dose,” to better
accommodate differences in metabolism among patients. “An increased
use of older kidneys, evaluated with
biopsy, would permit a successful expansion of the donor pool for older
patients, and would safely shorten the
waiting list.”
“Every transplant saves lives, and
the same can be said for costs,” said
David Axelrod, MD, assistant professor of surgery at Dartmouth Medical
School in Hanover, New Hampshire,
who spoke about the economics of
transplants with and without DGF.
Transplants are more expensive
than dialysis in the short run, he said,
but after a mean of 2.3 years for a living donor, or 3.6 years for a deceased
donor, the cost curves cross because
the recipient of a transplant requires
fewer medical services than does the
patient receiving dialysis. “The overall
cost of transplanting is less than the
cost of maintaining that same patient
on dialysis. As a society, we benefit
from kidney transplantation.”
But an aging recipient population,
and an increased use of ECD organs,
is taking a toll on the economics of
transplantation for the hospital. “Reimbursement costs have not kept pace
with operation costs,” he said. And
neither is reimbursement tied to the
quality of the kidney. As a result, “Delayed graft function largely determines
the overall margin for the hospital,”
Axelrod said.
Patients experiencing DGF have an
increase of about 50 percent in overall length of stay, not only for dialysis
but often also for cardiac care in the
intensive care unit, Axelrod said. His
analysis shows that DGF is a major
driver of Medicare payments, increasing the average reimbursement by
about $13,000. However, he said, the
hospital still lost about $5000 per patient because of the effects of DGF,
which increased to almost $11,000
with the combination of ECD and
DGF.
The indirect impact is also high,
with an increased risk for decreased
renal function and return to dialysis, and overall higher payments for
chronic kidney disease care. “The cost
of returning to dialysis is significant,”
he said.
So how can the risk of DGF be
reduced? Mechanical perfusion—
pumping—is one strategy, Axelrod
said. “The benefit of pumping is going to be on graft survival,” but not
necessarily on cost, according to his
analysis. “There is not much effect on
cost at 3 years. At worst, you could
say pumping is cost neutral.” Induction therapy, designed to induce tolerance for the new organ, is another
option to decrease the risk of acute
rejection after DGF. “We use induction therapy quite liberally,” Axelrod
said, “but these agents are not cheap.”
Other options were reviewed by
Douglas Hanto, MD, PhD, from
Beth Israel Deaconess Medical Center
in Boston. Dopamine, levothyroxine,
steroids, and vasopressin have all been
used. A new option may be carbon
monoxide, which, although toxic in
high doses, is released naturally within the body at very low doses during
hemoglobin catabolism and acts as a
cytoprotective and anti-inflammatory
agent through its ability to induce
stress response pathways.
Carbon monoxide can be delivered
as a gas. It has been shown to reduce
lung injury from hyperoxia and to
improve renal transplant outcomes in
animals when delivered to the recipient intraoperatively. There are no side
effects until the dose reaches twice the
effective dose, Hanto said. The clinical development of carbon monoxide
as an adjunct for transplantation is
currently stalled because the company developing the delivery system
is changing hands. “We think donor
treatment is probably also a good idea,
but that can be challenging,” because
it involves a tradeoff between taking
the time for treatment and reducing
the delay between removal of the donor kidney and transplantation.
Further research, all agreed, was
needed to better define the risk factors for DGF, the best ways to reduce
its incidence, and the optimal treatment strategies for patients who experience it.
AMERICAN SOCIETY OF NEPHROLOGY
CAREER FAIR
November 1st, 2nd & 3rd, 2012
9:30 AM – 2:30 PM
San Diego Convention Center
San Diego, California
Connect with top employers
looking to hire you.
Attend the American Society of Nephrology (ASN)
Kidney Week Career Fair at this year’s Annual Meeting
to connect with top employers looking to hire ASN
members! If you are unable to attend, simply upload
your CV/resume on the ASN website and allow Career
Fair employers to get in touch with you directly. Visit
http://careers.asn-online.org.
Employers, space is limited so
register as an exhibitor today.
To register your company as a Career
Fair exhibitor e-mail Jim Cook at
j.cook@jobtarget.com.
This event happens only once
per year so don’t miss it!
PRELIMINARY PROG
October 30–No
San Diego,
San Diego Conventio
Registration and General Housing Ope
www.asn-online.org/Kidn
6
| ASN Kidney News | August 2012
Findings: American Transplant Congress
How Can the Kidney Be Protected During Liver Transplantation?
K
idneys are at risk during and after
liver transplantation. How can
they be better protected? The prescription for intraoperative care is simple
to state, if difficult to achieve.
“The bottom line is that if we avoid
hypertension, avoid severe blood loss,
and avoid reperfusion injury, the kidney will be fine,” said Michael Ramsay,
MD, chief of service for the department
of anesthesiology and pain management
at Baylor University Medical Center in
Dallas, in a forum held in Boston at the
American Transplant Congress. “But the
question is, how do you do that?”
To give a sense of the scope of the
problem, Ramsay said that at his own
center, acute renal dysfunction occurs in
as many as 78 percent of patients intraoperatively. “So it happens, and it happens
because of all the rigors we have to put
the patients through during transplantation.” Factors that increase the risk of
renal injury include preexisting renal impairment, hemodynamic instability, perioperative bleeding, inflammation, and
abdominal compartment syndrome.
Changes in operative technique may
or may not have helped. The “piggyback”
technique is typically used to preserve the
patient’s own vena cava while controlling
blood flow during transplantation, and
it has largely supplanted the older technique of venovenous bypass. The latter
technique “is controversial, and is used
less these days,” Ramsay said. He noted
that a recent analysis of clinical trials in
one center where these options were used
concluded that piggyback alone resulted
in less transfusion, shorter stay in the
intensive care unit, and less acute renal
failure. However, that analysis compared
sequential, not concurrent, outcomes,
and a Cochrane review concluded that
there was no evidence to support or refute
venovenous bypass.
“It may be that once we get good biomarkers, that in those patients with significant hepatorenal dysfunction, some
form of bypass may be better for them,
but until we get that onsite, immediate
marker, I think it is going to be hard to
show,” he said.
Reperfusion syndrome can be a major
problem during surgery as well, increasing the risk of renal failure. “Severe hypotension, arrhythmia, cardiac arrest,
acidosis, fibrinolysis: this is a result of
all those bad things that are inside that
liver graft,” which accumulate during its
explantation, hitting the heart when flow
is restored through the implanted liver. It
occurs in about 25 percent of liver transplant recipients. The risk can be reduced
by flushing the graft out with saline before restoring flow to the heart, and also
by the prophylactic use of vasopressors,
Ramsay recommended.
Choice of immune suppression
therapy matters
Immune suppression can also lead to kidney injury, and the choice of agents may
have a big effect, said James Trotter, MD,
medical director of liver transplantation
at Baylor University Medical Center in
Dallas.
“By any measure, a substantial
number of patients come into liver transplant with renal dysfunction, and 30
percent have renal insufficiency,” meaning that many patients are already at risk
for posttransplant renal complications.
Twenty-eight percent of liver recipients
experience renal failure within 10 years of
transplantation, and one quarter of those,
he noted, do so within the first year. This
“front-loaded effect implicates the possibility of immunosuppression as a potential cause,” he said.
Calcineurin inhibitors (CNIs), including cyclosporine and tacrolimus, are probably the most important nephrotoxic agents
used. Cyclosporine can cause ischemia,
scarring, and fibrosis. As a result, “We’ve
had an evolution of how we handle immunosuppression over the past 20 years,” he
said. “To a large extent, avoidance of CNIs”
is a mainstay of protecting the kidney in the
context of liver transplantation.
Trotter noted that it is important to
distinguish between immunosuppression in the induction phase, or the first
few weeks after transplantation, and the
maintenance phase, many months to
years afterward.
The field is now moving toward biologic agents for induction, with such
agents as daclizumab and alemtuzumab,
and today about a quarter of patients
receive these. There is also a movement
toward using mycophenolates as CNIsparing agents, he said.
“Right now, the most common immunosuppressive regimen at the time of
discharge is mycophenolate plus CNIs,”
he said, accounting for 70 percent of patients, rather than using a CNI as monotherapy. Although the number of patients
never receiving a CNI is still small, that
number is growing as well.
“Liver transplant patients undergo
multiple hits to the kidney, on top of
likely having underlying kidney dysfunction,” which often ultimately leads to
chronic kidney disease, explained Josh
Levitsky, MD, of Northwestern University in Illinois.
“It would be extremely valuable to
have a biomarker that could identify who
is at increased risk of posttransplant kidney disease,” he said, in order to tailor
therapy to that risk. But such a biomarker
has been slow in coming.
He noted the important distinction
between diagnostic and predictive biomarkers. “Creatinine is not a good biomarker because injury has already occurred,” he said, and the same goes for
epidermal growth factor receptor and
proteinuria. “These are diagnostic, but
the goal is to push it ahead to prediction.” A good biomarker, he said, should
improve with successful intervention to
prevent progressive kidney injury. “That
would be a slam dunk.”
For acute kidney injury, the most
promising markers are neutrophil gelatinase–associated lipocalin, interleukin-18,
renal liver-type fatty acid binding protein,
cystatin C, and kidney injury molecule-1.
“But none provide a clear advantage beyond traditional clinical serum creatine,”
according to a recent review, he said.
And for predicting chronic kidney disease, “There is actually less data, and at
the present time, none are ready for use.”
In the search for such a predictive
marker, Levitsky and colleagues are first
looking retrospectively using serial collections of plasma, and comparing those
who experience chronic kidney disease
after transplantation with those whose
long-term renal function is stable. Ultimately, he said, this might help determine whether a liver transplant patient
would be better off with a simultaneous
liver-kidney transplant.
Regulation or Autonomy in Transplantation: A Debate
T
ransplant surgeons are among the
most innovative of physicians, and
they have to be: placing an organ
from one person into another is risky, even
under the best of conditions, and the shortage of organs has meant that surgery is often performed with less-than-ideal organs.
Although that willingness to take risks has
led to life-saving operations for many patients, not every outcome has been ideal,
and not every transplant program matches
the best centers in the level of patient care
it provides.
Given the tension between the benefits
of innovation and the costs of poor outcomes, what is the proper role of regulation? That was the topic of debate between
Thomas Hamilton, director of survey and
certification for the U.S. Center for Medicare and Medicaid Services (CMS), and
Dorry Segev, MD, PhD, associate professor of surgery at Johns Hopkins University,
speaking at the American Transplant Congress held in Boston in June.
“When there is a high level of complexity, and a high degree of trust is required,
these are environments that make regulation useful. That is true of the banking
industry, and it is also true of organ transplantation,” Hamilton said.
Segev countered, “If the system for
identifying consequences is not good, but
the consequences are severe, then riskaverse behavior will undoubtedly ensue.”
The CMS has regulated transplant centers since 2007, stepping in after many years
of a hands-off policy because of “a number
of headline articles” involving either questionable ethical practices or poor outcomes,
Hamilton said. “The problem is there are
always a certain number of outliers. That’s
what the regulations are designed to address. And this is not just in the public interest. CMS is the primary purchaser of or-
gan transplantation services in the world,”
and the regulations are the means for insisting on a certain basic level of outcome to
get the most value for public resources.
“There are bad regulations and there are
good regulations. At CMS, we are talented
in both directions,” Hamilton said. “Smart
regulations tend to be outcome focused,
rather than dictating every single step, and
they recognize unique circumstances, and
they promote self-governance and learning.” Those, he said, are the kind of regulations CMS uses to improve programs. A
center can be “flagged” for outcomes below
the expected range, after consideration of
the many factors involved, including patient and organ characteristics. But flagging
doesn’t close a center. “We provide the time
for programs to improve.” A “mitigating
factors” provision “allows a program to
come forward, and demonstrate how it has
turned the ship around,” Hamilton noted.
Some centers, he said, “are unacquainted with their own data,” and once they
understand the data better, they improve.
“Ninety percent of programs [which have
been flagged] have improved,” some dramatically so. “Ten percent, we invited to
voluntarily withdraw.”
The result, he said, is that “for every organ type, since 2007, we’ve seen a continued overall increase in survival. “So despite
acceptance of riskier organs and recipients,”
which has been a national trend, “the survival is going up. That is absolutely tremendous.”
Making the case for autonomy, Segev
stressed a distinction that is often lost when
outcomes between centers are compared.
“A transplant candidate is someone who
does better with a transplant than without
one, not someone who does better than
someone else,” he said. “The question is,
Continued on page 8
NOW APPROVED
Once-monthly OMONTYS
For further information, please visit www.omontys.com or call 1-855-GOMONTYS (1-855-466-6689).
INDICATION AND LIMITATIONS OF USE
OMONTYS® (peginesatide) Injection is indicated for the treatment of
anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
OMONTYS is not indicated and is not recommended for use in patients
with CKD not on dialysis, in patients receiving treatment for cancer and
whose anemia is not due to CKD, or as a substitute for red blood cell
(RBC) transfusions in patients who require immediate correction of anemia.
OMONTYS has not been shown to improve symptoms, physical functioning,
or health-related quality of life.
IMPORTANT SAFETY INFORMATION
WARNING: ESAs INCREASE THE RISK OF DEATH,
MYOCARDIAL INFARCTION, STROKE, VENOUS
THROMBOEMBOLISM, THROMBOSIS OF VASCULAR
ACCESS AND TUMOR PROGRESSION OR RECURRENCE.
Chronic Kidney Disease:
• In controlled trials, patients experienced greater risks for death,
serious adverse cardiovascular reactions, and stroke when
administered erythropoiesis-stimulating agents (ESAs) to target
a hemoglobin level of greater than 11 g/dL.
• No trial has identified a hemoglobin target level, ESA dose, or
dosing strategy that does not increase these risks.
• Use the lowest OMONTYS dose sufficient to reduce the need
for red blood cell (RBC) transfusions.
Contraindications
OMONTYS is contraindicated in patients with uncontrolled hypertension.
Warnings and Precautions
Increased mortality, myocardial infarction, stroke, and thromboembolism:
• Using ESAs to target a hemoglobin level of greater than 11 g/dL
increases the risk of serious adverse cardiovascular reactions and has
not been shown to provide additional benefit. Use caution in patients
with coexistent cardiovascular disease and stroke. Patients with CKD
and an insufficient hemoglobin response to ESA therapy may be at
even greater risk for cardiovascular reactions and mortality than other
patients. A rate of hemoglobin rise of >1 g/dL over 2 weeks may
contribute to these risks
• In controlled clinical trials of ESAs in patients with cancer, increased
risk for death and serious adverse cardiovascular reactions was
observed. These adverse reactions included myocardial infarction
and stroke
• In controlled clinical trials of ESAs, ESAs increased the risk of death
in patients undergoing coronary artery bypass graft surgery (CABG)
and deep venous thrombosis (DVT) in patients undergoing
orthopedic procedures
• In 2 trials of OMONTYS, patients with CKD not on dialysis experienced
increased specific cardiovascular events
Increased mortality and/or increased risk of tumor progression or
recurrence in patients with cancer: The safety and efficacy of OMONTYS
have not been established for use in patients with anemia due to cancer
chemotherapy. OMONTYS is not indicated in patients with cancer
receiving chemotherapy.
Hypertension: OMONTYS is contraindicated in patients with uncontrolled
hypertension. Appropriately control hypertension prior to initiation of and
during treatment with OMONTYS. Reduce or withhold OMONTYS if blood
pressure becomes difficult to control. Advise patients of the importance
of compliance with antihypertensive therapy and dietary restrictions.
Lack or loss of response to OMONTYS: For lack or loss of hemoglobin
response to OMONTYS, initiate a search for causative factors. If typical
causes of lack or loss of hemoglobin response are excluded, evaluate
for antibodies to peginesatide.
Dialysis management: Patients receiving OMONTYS may require
increased anticoagulation with heparin to prevent clotting of the
extracorporeal circuit during hemodialysis.
Laboratory monitoring: Evaluate transferrin saturation and serum ferritin
prior to and during OMONTYS treatment. Administer supplemental iron
therapy when serum ferritin is less than 100 mcg/L or when serum
transferrin saturation is less than 20%.
Adverse reactions
The most common adverse reactions in clinical studies in patients with
CKD on dialysis treated with OMONTYS were dyspnea, diarrhea, nausea,
cough, and arteriovenous fistula site complication.
Please see accompanying Brief Summary.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
03-12-00042-A.; DSG-00140. © 2012 Affymax, Inc. and Takeda Pharmaceuticals America, Inc. All rights reserved. Affymax, the Affymax logo, OMONTYS, and the OMONTYS logo are trademarks of Affymax, Inc. and/or its
subsidiaries. Takeda and the Takeda logo are trademarks of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.
8
| ASN Kidney News | August 2012
Debate
Continued from page 7
will this patient benefit from this procedure?”
Pressure to improve, he said, can and
does come from multiple other sources besides the CMS, including one’s self, one’s
fellow workers, and one’s colleagues in the
field. “This field has been doing this for 50some years, without a tremendous amount
of regulatory pressure, and outcomes have
become better every single year.” Segev
said. And the system of regulation, he said,
may not be very effective at identifying
which centers are doing well and which
are not. There are certainly centers that
perform below par and are flagged. Even
in these cases, Segev said, the consequence
could be that fewer patients benefit from
transplants. Remember the definition of
a transplant candidate, he said: someone
who does better with an organ than without one. Studies have shown that the effect
of flagging is to reduce transplant volumes
at the institution, reducing the number of
patients who benefit.
More troubling is that the model used
to flag institutions is imperfect and will
inevitably lead to flagging centers that are
performing at the norm. This, he said, is a
statistical artefact of the model. What happens when an artefact makes it seem as if
there is a problem when there isn’t? “What
happens when we try to improve outcomes
that don’t need improving? The answer is
we become more restrictive, because we
don’t know what else to do.”
To explore the risks of this scenario, Segev, who has a master’s degree in biostatistics, set up a simulation model. His model
included the same number of transplant
centers as there are in the United States,
with the same size distribution, and gave
every center the nationally expected outcomes. “Everybody did OK in this simulation,” he said. “Then we ran the [Program
Specific Report] methodology to see who
gets flagged.”
“When everybody is doing OK, when
nobody is working outside of the window
we want them to work in, there is an 11
percent chance that a center will be flagged
by the methodology at least once,” with
higher-volume centers far more likely to
be flagged than low-volume centers, even
if they are performing exactly the same.
In another simulation, he programmed
some centers to have higher risk, with
enough poor outcomes to trigger flagging,
but he found they were not being consistently flagged. “When there are centers
with worse outcomes, there is a16 percent
sensitivity for identifying those centers.”
And if a center was flagged, there was less
than a one-in-four chance that it was in
fact one of the poorly performing ones.
Finally, he said, the appropriate level
of risk may not be captured, leading the
center to appear to have worse outcomes
than it actually does, given the risks. “Our
ability to predict outcomes in transplantation, based on the data we’ve collected, is
just not very good at all.” but barely better
than a coin toss, he said.
Will We Ever Know the Long-Term Consequences for a
Living Kidney Donor?
A
family member, a loved one, or just
a Good Samaritan who contemplates donating a kidney naturally
wants to know what the effect may be on
his or her own long-term health. Although
many studies have attempted to address
this pressing question, there are few firstrate data, according to researchers speaking
at the American Transplant Congress in
Boston. And although several new studies
are under way to address the deficiencies
of the past, even these studies are rife with
problems, and definitive results may not be
available for years, if ever. “We need better information in this area,” according to
Amit Garg, MD, PhD, of London Health
Sciences Center in Ontario, “but there are
many challenges to getting it.”
“It is only in the last 10 years that there
has been enough activity to support large,
long-term studies,” he said. Even still, most
studies have been of questionable utility.
Single-center studies tend to have uniform
data but are too small to enable meaningful conclusions to be drawn. Multicenter
surveys tend to suffer from a high degree
of variability in practices between centers, especially across international borders.
Retrospective studies have the potential for
selection bias, whereas prospective studies,
7" x 10"
Brief Summary of Prescribing Information for:
OMONTYS (peginesatide) Injection for intravenous or subcutaneous use
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL
INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS
OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE.
See full prescribing information for complete boxed warning.
Chronic Kidney Disease:
• In controlled trials, patients experienced greater risks for death,
serious adverse cardiovascular reactions, and stroke when
administered erythropoiesis-stimulating agents (ESAs) to target a
hemoglobin level of greater than 11 g/dL.
• No trial has identified a hemoglobin target level, ESA dose, or
dosing strategy that does not increase these risks [see Warnings
and Precautions].
• Use the lowest OMONTYS dose sufficient to reduce the need for red
blood cell (RBC) transfusions [see Warnings and Precautions].
INDICATIONS AND USAGE
Anemia Due to Chronic Kidney Disease
OMONTYS is indicated for the treatment of anemia due to chronic kidney disease
(CKD) in adult patients on dialysis.
Limitations of Use
OMONTYS is not indicated and is not recommended for use:
• In patients with CKD not on dialysis because of safety concerns in this
population [see Warnings and Precautions].
• In patients receiving treatment for cancer and whose anemia is not due to
CKD, because ESAs have shown harm in some settings and the benefit-risk
factors for OMONTYS in this setting have not been evaluated [see Warnings
and Precautions].
• As a substitute for RBC transfusions in patients who require immediate
correction of anemia.
• OMONTYS has not been shown to improve symptoms, physical functioning
or health-related quality of life.
CONTRAINDICATIONS
OMONTYS is contraindicated in patients with:
• Uncontrolled hypertension [see Warnings and Precautions].
WARNINGS AND PRECAUTIONS
Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism
• In controlled clinical trials of other ESAs in patients with CKD comparing
higher hemoglobin targets (13 – 14 g/dL) to lower targets (9 - 11.3 g/dL)
(see Table 2), increased risk of death, myocardial infarction, stroke,
congestive heart failure, thrombosis of hemodialysis vascular access, and
other thromboembolic events was observed in the higher target groups.
• Using ESAs to target a hemoglobin level of greater than 11 g/dL
increases the risk of serious adverse cardiovascular reactions and has
not been shown to provide additional benefit. Use caution in patients with
coexistent cardiovascular disease and stroke. Patients with CKD and an
insufficient hemoglobin response to ESA therapy may be at even greater
risk for cardiovascular reactions and mortality than other patients. A rate
of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to
these risks.
• In controlled clinical trials of ESAs in patients with cancer, increased risk for
death and serious adverse cardiovascular reactions was observed. These
adverse reactions included myocardial infarction and stroke.
• In controlled clinical trials, ESAs increased the risk of death in patients
undergoing coronary artery bypass graft surgery (CABG) and deep venous
thrombosis (DVT) was observed in patients undergoing orthopedic procedures.
The design and overall results of 3 large trials comparing higher and lower
hemoglobin targets are shown in Table 2 (Normal Hematocrit Study (NHS),
Correction of Hemoglobin Outcomes in Renal Insufficiency (CHOIR) and Trial
to Reduce Cardiovascular Events with Aranesp® Therapy (TREAT)).
03-12-00042-A.; DSG-00140.
Table 2 Adverse Cardiovascular Outcomes in Randomized Controlled Trials
Comparing Higher and Lower Hemoglobin Targets in Patients with CKD
NHS
(N = 1265)
1993 to 1996
CHOIR
(N = 1432)
Time Period of Trial
2003 to 2006
Patients with CKD
Patients with CKD
not on dialysis with
on hemodialysis
hemoglobin
with coexisting CHF
Population
< 11 g/dL
or CAD, hematocrit
not previously
30 ± 3% on
administered
epoetin alfa
epoetin alfa
Hemoglobin Target;
Higher vs. Lower
14.0 vs. 10.0
13.5 vs. 11.3
(g/dL)
Median (Q1, Q3)
12.6 (11.6, 13.3) 13.0 (12.2, 13.4)
Achieved Hemoglobin
vs.
vs.
level (g/dL)
10.3 (10.0, 10.7) 11.4 (11.1, 11.6)
Primary Endpoint
TREAT
(N = 4038)
2004 to 2009
Patients with
CKD not on
dialysis with
type II diabetes,
hemoglobin
≤ 11 g/dL
13.0 vs. ≥ 9.0
12.5 (12.0, 12.8)
vs.
10.6 (9.9, 11.3)
All-cause mortality,
All-cause mortality,
All-cause mortality
MI, myocardial
MI, hospitalization
or non-fatal MI
ischemia, heart
for CHF, or stroke
failure, and stroke
Hazard Ratio or
Relative Risk
1.28 (1.06 – 1.56) 1.34 (1.03 – 1.74) 1.05 (0.94 – 1.17)
(95% CI)
Adverse Outcome for
All-cause mortality All-cause mortality
Stroke
Higher Target Group
Hazard Ratio or
Relative Risk
1.27 (1.04 – 1.54) 1.48 (0.97 – 2.27) 1.92 (1.38 – 2.68)
(95% CI)
Patients with Chronic Kidney Disease Not on Dialysis
OMONTYS is not indicated and is not recommended for the treatment of anemia
in patients with CKD who are not on dialysis.
A higher percentage of patients (22%) who received OMONTYS experienced a
composite cardiovascular safety endpoint event compared to 17% who received
darbepoetin alfa in two randomized, active-controlled, open-label, multi-center
trials of 983 patients with anemia due to CKD who were not on dialysis. The trials
had a pre-specified, prospective analysis of a composite safety endpoint consisting
of death, myocardial infarction, stroke, or serious adverse events of congestive
heart failure, unstable angina or arrhythmia (hazard ratio 1.32, 95% CI: 0.97, 1.81).
Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence
in Patients with Cancer receiving ESAs
OMONTYS is not indicated and is not recommended for reduction of RBC
transfusions in patients receiving treatment for cancer and whose anemia is not
due to CKD because ESAs have shown harm in some settings and the benefit-risk
factors for OMONTYS in this setting have not been evaluated.
The safety and efficacy of OMONTYS have not been established for use in patients
with anemia due to cancer chemotherapy. Results from clinical trials of ESAs
in patients with anemia due to cancer therapy showed decreased locoregional
control, progression-free survival and/or decreased overall survival. The findings
were observed in clinical trials of other ESAs administered to patients with: breast
cancer receiving chemotherapy, advanced head and neck cancer receiving radiation
therapy, lymphoid malignancy, cervical cancer, non-small cell lung cancer, and
with various malignancies who were not receiving chemotherapy or radiotherapy.
Hypertension
OMONTYS is contraindicated in patients with uncontrolled hypertension.
Appropriately control hypertension prior to initiation of and during treatment with
OMONTYS. Reduce or withhold OMONTYS if blood pressure becomes difficult to
control. Advise patients of the importance of compliance with antihypertensive
therapy and dietary restrictions.
Lack or Loss of Response to OMONTYS
For lack or loss of hemoglobin response to OMONTYS, initiate a search for
causative factors (e.g., iron deficiency, infection, inflammation, bleeding). If
typical causes of lack or loss of hemoglobin response are excluded, evaluate
the patient for the presence of antibodies to peginesatide. In the absence of
antibodies to peginesatide, follow dosing recommendations for management
of patients with an insufficient hemoglobin response to OMONTYS therapy.
Contact Affymax, Inc. (1-855-466-6689) to perform assays for binding and
neutralizing antibodies.
Dialysis Management
Patients may require adjustments in their dialysis prescriptions after initiation of
OMONTYS. Patients receiving OMONTYS may require increased anticoagulation
with heparin to prevent clotting of the extracorporeal circuit during hemodialysis.
Laboratory Monitoring
Evaluate transferrin saturation and serum ferritin prior to and during OMONTYS
treatment. Administer supplemental iron therapy when serum ferritin is less
than 100 mcg/L or when serum transferrin saturation is less than 20%. The
majority of patients with CKD will require supplemental iron during the course
August 2012 | ASN Kidney News |
as others have detailed, have been hampered
by the ability to recruit and retain control
participants for very-long-term follow-up.
Didier Mandelbrot, MD, medical director of the living kidney donor program at
Beth Israel Deaconess Medical Center in
Boston, noted that the need for living donors arises from the huge disparity between
the need for kidneys and the supply. In addition, living donation has several benefits for
recipients, including minimal waiting time
(versus an average of 3–5 years for a kidney from a deceased donor), reduced need
for dialysis, longer survival of the graft, and
longer survival of the patient. Of the 15,000
kidney transplants in the United States every year, about 6000 are from living donors;
more than 90,000 living donor transplantation procedures have been performed over
the past 20 years.
A 2009 study in the New England Journal of Medicine indicated that the long-term
survival of donors was no different from that
of matched control individuals, but some
questions have remained about the adequacy of the control in this study.
A critical unanswered question, Mandelbrot said, is who is an acceptable living do-
nor? Should the decision hinge on kidneyspecific factors, such as creatinine clearance?
What else must be considered? “I think it
is fair to say there are no long-term data to
guide us,” he said. The effects of donation
are better known for the most typical donors—young, healthy, white persons—“but
what are the long-term outcomes in more
borderline patients?”
One potential source for information
might be follow-up data kept by the United
Network for Organ Sharing, the organization that manages donations in the United
States. But there is a steep dropoff in the
7" x 10"
of ESA therapy. Following initiation of therapy and after each dose adjustment,
monitor hemoglobin every 2 weeks until the hemoglobin is stable and sufficient
to minimize the need for RBC transfusion. Thereafter, hemoglobin should be
monitored at least monthly provided hemoglobin levels remain stable.
ADVERSE REACTIONS
The following serious adverse reactions observed during clinical trials with
OMONTYS are discussed in greater detail in other sections of the labeling:
• Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism
[see Warnings and Precautions]
• Hypertension [see Warnings and Precautions]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical studies of OMONTYS cannot be directly
compared to rates in the clinical trials of other drugs and may not reflect the
rates observed in practice.
Patients with Chronic Kidney Disease
Adverse reactions were determined based on pooled data from two active
controlled studies of 1066 dialysis patients treated with OMONTYS and
542 treated with epoetin, including 938 exposed for at least 6 months and
825 exposed for greater than one year to OMONTYS. The population for
OMONTYS was 20 to 93 years of age, 58.5% male, and the percentages of
Caucasian, Black (including African Americans), and Asian patients were 57.9%,
37.4%, and 3.1%, respectively. The median weight adjusted dose of OMONTYS
was 0.07mg/kg and 113 U/week/kg of epoetin.
Table 3 summarizes the most frequent adverse reactions (≥ 10%) in dialysis
patients treated with OMONTYS.
Table 3 Adverse Reactions Occurring in ≥10% of Dialysis Patients treated
with OMONTYS
Adverse Reactions
Dialysis Patients
Treated with
OMONTYS
(N = 1066)
Gastrointestinal Disorders
Diarrhea
18.4%
Nausea
17.4%
Vomiting
15.3%
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea
18.4%
Cough
15.9%
Injury, Poisoning and Procedural Complications
Arteriovenous Fistula
16.1%
Site Complication
Procedural Hypotension
10.9%
Nervous System Disorders
Headache
15.4%
Musculoskeletal and Connective Tissue Disorders
Muscle Spasms
15.3%
Pain in Extremity
10.9%
Back Pain
10.9%
Arthralgia
10.7%
Vascular Disorders
Hypotension
14.2%
Hypertension
13.2%
General Disorders and Administration Site Conditions
Pyrexia
12.2%
Metabolism and Nutrition Disorders
Hyperkalemia
11.4%
Infections and Infestations
Upper Respiratory Tract Infection
11.0%
Dialysis Patients
Treated with
Epoetin
(N = 542)
15.9%
19.6%
13.3%
19.4%
16.6%
16.6%
12.5%
15.9%
17.2%
12.7%
11.3%
9.8%
14.6%
11.4%
14.0%
11.8%
12.4%
Seizures have occurred in patients participating in OMONTYS clinical studies. During
the first several months following initiation of OMONTYS, blood pressure and the
presence of premonitory neurologic symptoms should be monitored closely.
Advise patients to contact their healthcare practitioner for new-onset seizures,
premonitory symptoms, or change in seizure frequency.
Allergic reactions have been reported in patients treated with
OMONTYS. Discontinue OMONTYS and administer appropriate therapy if a
serious allergic, anaphylactic or infusion-related reaction occurs.
Immunogenicity
Of the 2357 patients tested, 29 (1.2%) had detectable levels of peginesatidespecific binding antibodies. There was a higher incidence of peginesatide-specific
03-12-00042-A.; DSG-00140.
binding antibodies in patients dosed subcutaneously (1.9%) as compared to
those dosed intravenously (0.7%). Peginesatide neutralizing antibodies were
detected in vitro using a cell-based functional assay in 21 of these patients
(0.9%). In approximately half of all antibody-positive patients, the presence of
antibodies was associated with declining hemoglobin levels, the requirement for
increased doses of OMONTYS to maintain hemoglobin levels, and/or transfusion
for anemia of CKD. No cases of pure red cell aplasia (PRCA) developed in
patients receiving OMONTYS during clinical trials.
DRUG INTERACTIONS
No formal drug/drug interaction studies have been performed. Peginesatide does
not bind to serum albumin or lipoproteins as demonstrated in in vitro protein
binding studies in rat, monkey and human sera. In vitro studies conducted with
human hepatocytes or microsomes have shown no potential for peginesatide
to induce or inhibit CYP450 enzymes.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women.
Peginesatide was teratogenic and caused embryofetal lethality when
administered to pregnant animals at doses and/or exposures that resulted in
polycythemia. OMONTYS should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
Administration of peginesatide by intravenous injection to rats and rabbits during
organogenesis was associated with embryofetal toxicity and malformations.
Dosing was every third day in rats for a total of 5 doses and every fifth day
in rabbits for a total of 3 doses (0.01 to 50 mg/kg/dose). In rats and rabbits,
adverse embryofetal effects included reduced fetal weight, increased resorption,
embryofetal lethality, cleft palate (rats only), sternum anomalies, unossification
of sternebrae and metatarsals, and reduced ossification of some bones.
Embryofetal toxicity was evident in rats at peginesatide doses of ≥ 1 mg/kg
and the malformations (cleft palate and sternoschisis, and variations in blood
vessels) were mostly evident at doses of ≥ 10 mg/kg. The dose of 1 mg/kg
results in exposures (AUC) comparable to those in humans after intravenous
administration at a dose of 0.35 mg/kg in patients on dialysis. In a separate
embryofetal developmental study in rats, reduced fetal weight and reduced
ossification were seen at a lower dose of 0.25 mg/kg. Reduced fetal weight
and delayed ossification in rabbits were observed at ≥ 0.5 mg/kg/dose of
peginesatide. In a separate embryofetal developmental study in rabbits, adverse
findings were observed at lower doses and included increased incidence of fused
sternebrae at 0.25 mg/kg. The effects in rabbits were observed at doses lower
(5% - 50%) than the dose of 0.35 mg/kg in patients.
Nursing Mothers
It is not known whether peginesatide is excreted in human milk. Because
many drugs are excreted into human milk, caution should be exercised when
OMONTYS is administered to a nursing woman.
Pediatric Use
The safety and efficacy of OMONTYS in pediatric patients have not
been established.
Geriatric Use
Of the total number of dialysis patients in Phase 3 clinical studies of OMONTYS,
32.5% were age 65 and over, while 13% were age 75 and over. No overall
differences in safety or effectiveness were observed between these subjects
and younger subjects.
OVERDOSAGE
OMONTYS overdosage can elevate hemoglobin levels above the desired level,
which should be managed with discontinuation or reduction of OMONTYS
dosage and/or with phlebotomy, as clinically indicated. Cases of severe
hypertension have been observed following overdose with ESAs [see Warnings
and Precautions].
PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide).
Marketed by:
Affymax, Inc.
Palo Alto, CA 94304
Distributed and Marketed by:
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015
For more detailed information, see the full prescribing information for OMONTYS
at www.omontys.com or contact Takeda Pharmaceuticals America, Inc.
OMONTYS is a trademark of Affymax, Inc. registered in the U.S. Patent and
Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.
All other trademarks are the property of their respective owners.
©2012 Takeda Pharmaceuticals America, Inc.
March 2012
PEG096 R1
L-DSG-0312-1
03-12-00027-A.; DSG-00057.
9
percentage of donors seen postoperatively
over time, with fewer than half returning at
1 year and only 7 percent at 5 years.
An attempt to overcome this lack of
information is under way with the Kidney Donor Outcomes Cohort (KDOC)
study (www.kdocstudy.com). KDOC is
a prospective study that will assess living
donors for psychological, social, functional, surgical, and medical outcomes. As of
May 2012, the study has enrolled 74 of
a planned 280 donors. Enrolling healthy
control individuals has been more of a
challenge, Mandelbrot said.
Other studies have faced different challenges. Alan Leichtman, MD, of the University of Michigan, described the Renal
and Lung Living Donors Evaluation (RELIVE) study, a joint effort among several
national kidney transplant centers. Earlier
iterations of the study were retrospective or
cross-sectional, whereas the current one is
prospective. The goal is to assess outcomes
in almost 9000 donors over time, combining information from multiple datasets,
including transplant center records, Medicare and Medicaid records, the National
Death Index, and, for control individuals,
the National Health and Nutrition Examination Survey (NHANES).
Much of the work has been resolving discrepancies among the sets. “It is an
enormous amount of work,” Leichtman
said. The payoff is that the comprehensiveness of the approach “should allow a high
probability of accurately estimating the frequency of common postdonation events.”
Bertram Kasiske, MD, professor of
medicine and head of transplant nephrology at the University of Minnesota, reported on the Assessing Long-term Outcomes
after Living Kidney Donation (ALTOLD)
study. This prospective trial, at eight sites
in the eastern and central United States,
aimed to enroll 200 donors plus paired
control individuals, with a 36-month
follow-up. “We were perhaps a bit naïve.
We wanted to look at living unrelated donors, and find controls through siblings,”
but that proved too challenging. “We gave
up being purists,” he said. The researchers
expanded their enrollment to include any
living donors and nonsibling control individuals.
After 6 months, their original 204 donors had dropped to 198. Currently, they
have 80 percent of the original cohort out
to 24 months.
Given the enormous challenges, expense, and difficulties of conducting such
long-term studies, one audience member suggested, “Perhaps we are trying to
achieve something we can never achieve.”
Instead, perhaps the focus should be on
teaching donors to understand that any increase in risk is likely to be quite small and
to help them find healthy ways of dealing
with the inevitable uncertainty after their
generous gift.
Mandelbrot offered some support to
that idea. “We may have to accept the fact
that we will never know what we want to
know,” he concluded—that is, how donors
do over the very long term. “We may have
to accept there will always be uncertainty.”
Leichtman countered that there was no
reason to accept the fatalism of that view.
“It would be a shame if, 50 years from now,
we were still bemoaning that we didn’t have
the data,” he said.
American Society of Nephrology
Kidney Week: October 30 – November 4
Exhibit Dates: November 1 – 3
Registration and Housing Now Open
www.asn-online.org/KidneyWeek
August 2012 | ASN Kidney News |
11
Peritoneal Dialysis
Trends in Outcomes of Peritoneal
Dialysis Patients in the United States
By Rajnish Mehrotra
I
n the 1960s, peritoneal dialysis for the treatment of uremia was performed intermittently. Patients would come in to receive treatment for 10 to 24 hours or more at a time, two to four times
weekly. It was soon recognized that intermittent peritoneal dialysis did not provide adequate
control of uremia and this approach was abandoned in favor of thrice-weekly hemodialysis. This
changed in 1975 with the successful treatment of one patient with peritoneal dialysis performed
continuously, rather than intermittently, while living at home, rather than in a healthcare setting.
The delivery of continuous peritoneal dialysis has substantially improved over the
last three decades. It is estimated that about 15 percent of the dialysis population
worldwide uses the therapy now. The proportion of dialysis patients in the United
States treated with peritoneal dialysis is about 7 percent.
As more patients with ESRD began treatment with peritoneal dialysis, the question of whether patients do as well when treated with this form of dialysis compared
to in-center hemodialysis gained importance. Most studies have examined patient
survival, and the discussion herein will be limited to this issue.
Initial studies were small, often from a single center. Since the 1990s, a large
number of studies have used information from all ESRD patients in any given country from different parts of the world. The studies from the 1990s showed that patients who started treatment with peritoneal dialysis had a lower chance of dying
in the first 2 to 3 years of starting dialysis compared to those who started treatment
with hemodialysis. The apparent “benefit” of treatment with peritoneal dialysis was
greatest for the youngest and healthiest patients and least for the oldest and sickest
patients. However, the long-term death risk was seemingly greater for peritoneal dialysis patients compared to those treated with hemodialysis. These studies showing an
apparent change in death risk over time were interpreted as reflecting the advantages
and disadvantages of each individual dialysis therapy. This interpretation has led to
the widespread perception that peritoneal dialysis is a good therapy for some, but
not all patients. Moreover, it is believed that peritoneal dialysis can be used for only
a short period of time, generally for only as long as patients with ESRD make at least
some urine.
Over the past decade, the survival of patients who start treatment with peritoneal
dialysis has improved significantly more than that of in-center hemodialysis patients.
Greater improvements in survival of peritoneal dialysis than of hemodialysis patients
have been reported from North America (United States and Canada), Europe (France
and Denmark), Asia (Taiwan), and Oceania (Australia and New Zealand).
Studies of patients who have started treatment with dialysis therapies in the 21st
century show that the 4-, 5-, and 10-year survival of peritoneal dialysis and hemodialysis patients in the contemporary era are virtually identical (1–3). This equivalency
in outcomes with peritoneal dialysis and hemodialysis has been reported from North
and South America, Europe, Asia, and Oceania (4–7). These studies challenge the
traditional paradigm of which patient with ESRD should be treated with peritoneal
dialysis and for how long (8). It would seem that there are no meaningful differences
in patient survival with peritoneal dialysis and hemodialysis. Thus patient survival
should not be a consideration when patients are counseled about the different renal
replacement therapies.
Few treatments impact so many aspects of an individual’s life as dialysis therapy
does. Given the overall equivalency of patient survival with the two therapies, the
overwhelming majority of patients can and should choose which dialysis therapy
they will use, on the basis of lifestyle considerations with active support and guidance
from the healthcare staff.
Rajnish Mehrotra, MD, is section head of nephrology with the Harborview Medical Center
at the University of Washington in Seattle, WA.
References
1. Weinhandl ED, Foley RN, Gilbertson DT, et al. Propensity-matched mortality
comparison of incident hemodialysis and peritoneal dialysis patients. J Am Soc Nephrol 2010; 21:499–506.
2. Mehrotra R, Chiu YW, Kalantar-Zadeh K, Bargman J, Vonesh E. Similar outcomes
with hemodialysis and peritoneal dialysis in patients with end-stage renal disease.
Arch Intern Med 2011; 171:110–8.
3. United States Renal Data System. U.S. Department of Public Health and Human
Services, Public Health Service, National Institutes of Health, Bethesda 2011.
4. Yeates K, Zhu N, Vonesh E, Trpeski L, et al. Hemodialysis and peritoneal dialysis are
associated with similar outcomes for end-stage renal disease treatment in Canada.
Nephrol Dial Transplant 2012. Epub 2012/03/07.
5. Sanabria M, Munoz J, Trillos C, et al. Dialysis outcomes in Colombia (DOC) study:
a comparison of patient survival on peritoneal dialysis vs. hemodialysis in Colombia.
Kidney Int Suppl. 2008: S165–72.
6. Grenêche S, D’Andon A, Jacquelinet C, Faller B, Fouque D, Laville B. Choosing
between peritoneal dialysis and haemodialysis: a critical appraisal of the literature.
Néphrologie & Thérapeutique 2005; 1:213–20.
7. McDonald SP, Marshall MR, Johnson DW, Polkinghorne KR. Relationship between
dialysis modality and mortality. J Am Soc Nephrol 2009; 20:155–63.
8. Mehrotra R. Choice of dialysis modality. Kidney Int 2011; 80:909–11.
The List: ASN Kidney
News “What
to Watch” in 2011
Peritoneal
Dialysis
Organization and Structure of a Successful Peritoneal
Dialysis Program
By Fredric O. Finkelstein
O
ne important reason for the limited use of peritoneal dialysis in the United States involves
problems with the organization of peritoneal dialysis
facilities. The basic structure and function of peritoneal dialysis facilities needs to be quite different from
that of in-center hemodialysis facilities. Four key elements need to be addressed in organizing a peritoneal
dialysis facility:
• Adequate chronic kidney disease (CKD) education program
• Adequate size and structure of peritoneal dialysis
centers
• Development of appropriate support systems: a
team approach
• Development of appropriate continuous quality
improvement (CQI) programs to monitor a variety of domains
CKD education
The importance of developing and implementing adequate CKD education programs cannot be overemphasized. The vast majority of CKD patients do not have
contraindications to receiving peritoneal dialysis. The
majority of patients approaching ESRD have surprisingly little knowledge about treatment options. This
occurs even if patients have been referred to nephrologists, indicating that the process of providing education for CKD patients needs to be reexamined. Funds
should be allocated to support education programs
and train educators and to incorporate CKD education into the routine fabric of care.
Center size
Several studies have documented the impact of center
size on the outcome in patients receiving peritoneal
dialysis. In terms of peritonitis rates, technique failure,
and mortality rates, smaller units tend to have worse
outcomes. The reasons likely relate to the experience
of nurses and physicians, the ability to develop a support team, and the development of effective CQI programs. It has been suggested that the growth of peritoneal dialysis programs in the United States has been
limited by the attempts to grow small peritoneal dialysis programs rather than the consolidation of small
peritoneal dialysis programs into larger centers. Certainly, the experience in the Far East suggests that large
programs may be extremely successful. Many programs
in China, Taiwan, and Hong Kong care for more than
300 peritoneal dialysis patients and report excellent results of this therapy, with low rates of peritonitis and
technique failure.
Appropriate support systems: a team
approach
The peritoneal dialysis unit needs to use a team approach to treating the patient. Nurses are the backbone
of the program. Nurses who are dedicated to the peritoneal dialysis program, have sufficient experience, and
are readily available to patients 24 hours a day are critically important to program success. Social work and
dietary input are also crucial ingredients for a successful program. Psychosocial assessments and interventions are particularly important for patients receiving
maintenance therapy at home because various psychosocial factors can have an adverse impact on outcomes,
including depression and anxiety in patients and stress
in caregivers. Attention to dietary input is also essential. The importance of sodium restriction in terms of
controlling blood pressure and limiting the dextrose
exposure required to maintain fluid balance with peritoneal dialysis needs to be emphasized. Limitations of
phosphate clearance with peritoneal dialysis require
that careful attention be paid to restriction of dietary
phosphate and compliance with the administration of
phosphorus binders.
CQI programs
CQI programs are critical to the success of a peritoneal
dialysis program, as has been discussed in the KDOQI
guidelines. A modification of the domains suggested in
the KDOQI guidelines for CQI is summarized in Table 1. Successful peritoneal dialysis programs need to
track their outcomes and address the important areas
that affect the outcomes in peritoneal dialysis patients.
Difficulties in managing a peritoneal dialysis unit vary
from facility to facility, and each facility must identify
and deal with the problem areas that are unique to its
program.
Fredric O. Finkelstein, MD, is affiliated with the Hospital of St. Raphael, Yale University, New Haven, CT.
Table 1. Continuous quality
improvement domains
1.
Peritonitis rates
2.
Exit site infection rates
3.
Technique failure rates
4.
Patient satisfaction
5.
Health-related quality of life
6.
Catheter-related problems and catheter
survival rates
7.
Adequacy of dialysis
8.
Anemia management
9.
Calcium and phosphorus metabolism
10.
Blood pressure and volume control
11.
Lipid control
12.
Weight management
13.
Dextrose use
Dr. Gregory Braden interviews Gayle Gray, peritoneal dialysis
patient for three years
Dr. Braden Gayle, I know you just received a kidney transplant and are doing
great with it, but how long were you on peritoneal dialysis?
Gayle Gray I was on peritoneal dialysis for three years.
Dr. Braden Why did you choose peritoneal dialysis instead of in-center hemodialysis or home hemodialysis?
Gayle Gray I chose peritoneal dialysis because I didn’t want to have the ups and
downs of both fluid and toxin removal, which I did not think would
be good for my body since I have had type 1 diabetes for the last 35
years.
Dr. Braden Why did you choose continuous ambulatory peritoneal dialysis
(CAPD) over CCPD (continuous cycling peritoneal dialysis)?
Gayle Gray I did not have enough room in my bedroom to store all the supplies
and the machine for CCPD. In addition, I have to get up at night to
go to the bathroom often and I did not want to have to use a bedside
commode.
Dr. Braden What do you feel were the greatest benefits of performing home peri-
toneal dialysis?
Gayle Gray I enjoyed doing home peritoneal dialysis because I was playing an
active role in my care. I have to watch my diabetes carefully, and
although the sugar in the fluid caused me to use more insulin, with
peritoneal dialysis I thought I was in charge of my health.
Dr. Braden Do you have any regrets about your decision to perform home peritoneal dialysis?
Gayle Gray As I look back on my three years of dialysis I really have no regrets.
I know that I live in an old house and I live with my older parents
and I even had at times to do the exchanges in the bathroom with the
door closed so there was no air moving, but overall I am glad I did
it. It would have been nice if my house was larger, but it just wasn’t.
Also when I look at my body after peritoneal dialysis I did have some
abdominal skin stretching and weakened abdominal muscles from
the 2 liters of abdominal fluid with each exchange.
Gregory Braden, MD, is fellowship director and chief of the nephrology division at Baystate Medical Center/Tufts University School of Medicine in Springfield, MA.
August 2012 | ASN Kidney News |
13
Physician Education in Care of Peritoneal Dialysis Patients
During Fellowship and Beyond: Opportunities and Challenges
By Joni H. Hansson
T
he use of peritoneal dialysis for treatment of ESRD in
the United States has remained low (approximately 7
percent) despite an expanding number of patients reaching
ESRD. It has been suggested that limited fellowship training
in peritoneal dialysis may be one of the factors contributing
to this decline, because this can result in provider inexperience and bias against peritoneal dialysis as a modality for
treating ESRD.
The Accreditation Council for Graduate Medical Education program requirements for graduate medical education
in nephrology state: “Fellows must have formal instruction,
specialized clinical experience and demonstrate competence
in dialysis,” which includes peritoneal dialysis. Over the
past decade, several surveys have examined dialysis training
from the perspective of program directors and graduates. In
general, it is thought that fellowship training in peritoneal
dialysis is inadequate and needs to be improved. Less time
is spent with didactic teaching and direct care of peritoneal
dialysis patients in comparison with hemodialysis. In fact,
fellows in most training programs follow up five or fewer
peritoneal dialysis patients in the ambulatory setting during
their fellowship.
To address the concerns of fellowship education in peritoneal dialysis, several educational initiatives have been
developed (Table 1). Several educational courses are now
available for peritoneal dialysis. The Peritoneal Dialysis University, developed in 1999 and now known as Home Dialysis University, is a 2.5-day course offered four to five times
a year. Many training programs use these courses to supplement their curriculum for their fellows.
Unfortunately, not all fellows (or nephrologists wishing
to expand their knowledge of peritoneal dialysis) can attend
one of these conferences. This led to a collaborative effort of
the training program directors, the ASN Dialysis Advisory
Group and the North American Chapter (NAC) of the International Society of Peritoneal Dialysis (ISPD) to develop
a comprehensive curriculum in peritoneal dialysis that is
available online for all to use. This curriculum contains 20
presentations with references and questions to test learning.
It includes peritoneal dialysis basics, management and complications of peritoneal dialysis, educational resources, and
special topics. The ASN Dialysis Advisory Group has developed the ASN Virtual Mentor Dialysis Curriculum, which
is also freely accessible online and covers all aspects of dialysis, including peritoneal dialysis. These educational resources
offer wonderful opportunities for fellows, nephrologists, and
other health care providers to learn all aspects of peritoneal
dialysis.
Our greatest educational challenge is ensuring an adequate patient care experience in peritoneal dialysis. Many
fellowship programs have limited exposure to the care of
patients receiving peritoneal dialysis, either because of a
small number of peritoneal dialysis patients at that institution or because of scheduling conflicts with other fellowship
requirements. Fellowship programs must ensure that time is
built into the fellow’s schedule for an ambulatory peritoneal
dialysis experience, and they should consider using local offsite clinics within or outside the institution.
Future educational initiatives should focus on novel programs to provide a meaningful experience with ambulatory
peritoneal dialysis so that fellows can learn how to treat patients receiving peritoneal dialysis and understand how to
develop and structure a peritoneal dialysis program. For
example, training sites could be developed in large successful peritoneal dialysis units across the country that have a
standardized experiential curriculum for the care of peritoneal dialysis patients. Programs with limited peritoneal dialysis patients could send their fellows to such a program
for 1 week. A precedent for such a program exists through
initiatives in Toronto and New Haven. Another example is
faculty development (“train the trainer”) in peritoneal dialysis, so that faculty will embrace and grow peritoneal dialysis
programs at their institutions. This could be accomplished
by developing a resource/mentoring programs for nephrologists interested in expanding peritoneal dialysis in their
practices. All these initiatives, it is hoped, will enhance the
educational experience that fellows will have in caring for
patients receiving peritoneal dialysis.
Fellowship training in peritoneal dialysis is quite variable
and needs to be improved. This has led to the development
of multiple educational resources in the care of patients receiving peritoneal dialysis. However, in the future we need
to focus on how to enhance and ensure a direct patient care
experience in peritoneal dialysis. Knowledge and experience
will result in the growth of peritoneal dialysis as a modality for ESRD and also will improve fellowship training and
patient outcomes.
Joni H. Hansson, MD, is nephrology fellowship program director at the Hospital of Saint Raphael and assistant clinical professor at Yale University School of Medicine in New Haven, CT.
Table 1. Educational resources for training in peritoneal dialysis
NAC-ISPD Comprehensive Peritoneal Dialysis Curriculum
http://ispd.org/NAC/education/pd-curriculum/
ASN Virtual Mentor Dialysis Curriculum
http://www.asn-online.org/education_and_meetings/distancelearning/curricula/dialysis/
Home Dialysis University
http://www.hdufellows.com/
https://secure.lenos.com/lenos/northpointe/HDUPhysiciansPage/
2011 Corporate Supporters
The ASN Corporate Support Program recognizes supporters year round for their generous contributions to the Society. Through
this program, supporters help ASN lead the fight against kidney disease. ASN gratefully acknowledges the following companies
for their contributions in 2011.
Diamond Level
Platinum Level
Gold Level
Alexion
Fresenius Medical Care
Merck & Co., Inc.
Mitsubishi Tanabe Pharma
Questcor
Silver Level
Bronze Level
Affymax
DaVita
AMAG
Astellas
AstraZeneca
Gambro
Genentech, A Member of the Roche Group
Savient Pharmaceuticals, Inc.
Shire
The List: ASN Kidney
News “What
to Watch” in 2011
Peritoneal
Dialysis
Enhancing Nursing and Allied Staff Peritoneal Dialysis
Education in a Chronic Kidney Disease Program
By Beth Piraino and Judith Bernardini
T
he option of peritoneal dialysis for management of
advanced chronic kidney disease (CKD) is best introduced while the patient is being followed up in the CKD
clinic. Educational approaches to patients with CKD include classes, instruction one-on-one by a nurse educator
or other allied health care professional, and information
provided by the physician. A team approach is often used in
peritoneal dialysis education as part of a well-run CKD program. Therefore, all members of the team should be fully informed and up to date about peritoneal dialysis. The CKD
team may include medical assistants, physician assistants,
nurse practitioners, dieticians, nurses, and renal fellows as
well as nephrologists. Education about peritoneal dialysis
should be provided to these important team members.
Educating allied health care professionals about peritoneal dialysis, a modality with which many are unfamiliar,
ensures that all speak with informed voices and avoid giving
incorrect information about peritoneal dialysis. It is rather
common for those with little knowledge about peritoneal
dialysis to tell patients that the procedure is associated with
a high risk of infection, thus discouraging patients from
home peritoneal dialysis. Patients may also have obtained
information about renal replacement therapy from the Internet (1). Although some websites have factually, clearly
presented information, others are inaccurate and may be
self-serving. It is quite possible that allied health care professionals have likewise been exposed to incorrect information about peritoneal dialysis, and this may unfortunately
reinforce a patient’s wrong perceptions. Therefore, a structured approach to educating staff members of the CKD
clinic about peritoneal dialysis seems desirable.
CKD patients with GFR levels of 20 mL/min or lower
who are aware that dialysis will be likely needed in their future often have major depression (25 percent) or subthreshold depression (20 percent) according to structured psychiatric interviews (2). The team approach for these patients
provides support and correct information in a longitudinal
fashion. Many CKD clinics do not have the services of a
social worker, so other allied health care professionals must
provide such support and psychological insight. Sequential
measures of depression, loneliness, and isolation might be
useful in this setting. Some patients use avoidance, which
results in faster progression of CKD (3). Patients facing
dialysis who have greater psychological stress levels related
to CKD as measured by the Chronic Kidney Disease Stress
Inventory are more likely to start dialysis with in-center
hemodialysis than with peritoneal dialysis (4). It seems
probable that support by a well-educated CKD team will
diminish stress in this setting.
Table 1 shows resources for teaching health care professionals about peritoneal dialysis. Most of the information
would be suitable for physician assistants, nurse practitioners, nurses, and social workers who work in the CKD
clinic. The best approach to training these allied health
care professionals is not known, but it might include attendance at one of the meetings listed, regular reading of
the journal Peritoneal Dialysis International, and a review
of the free slide set put together by expert members of the
International Society for Peritoneal Dialysis North American Chapter (ISPD NAC) available at the ISPD website
(http://ispd.org/NAC/education/pd-curriculum). A peritoneal dialysis expert in the program could present the slide
sets to the health care professionals working in the CKD
program.
To summarize, little is known about the level of knowledge regarding peritoneal dialysis among allied health care
professionals who work in CKD clinics. It appears probable that knowledge of peritoneal dialysis is variable and
often lacking. A well informed approach to educating the
allied health care professionals in the CKD clinic about
peritoneal dialysis as an option for patients should enable
the entire team to support the patient to make informed
choices. This is a fertile area for further research.
Beth Piraino, MD, is professor of medicine at the University
of Pittsburgh School of Medicine and Judith Bernardini, RN,
is adjunct assistant professor at the University of Pittsburgh
School of Nursing and Medical School.
References
1. Buettner K, Fadem SZ. The internet as a tool for
the renal community. Adv Chronic Kidney Dis 2008;
15:73–82.
2. Piraino B, Bernardini J, Wilson T, et al. Assessment
of depression in patients with chronic kidney disease
(CKD) and impending dialysis. J Am Soc Nephrol
2003; 14:448A.
3. Devins G, Mendelssohn D, Barre P, et al. Predialysis
psychoeducational intervention and coping styles influence time to dialysis in chronic kidney diseae. Am J
Kidney Dis 2003; 42:693–703.
4. Harwood L, Wilson B, Sontrop J, et al. Chronic kidney disease stressors influence choice of dialysis modality J Adv Nurs 2012, in press.
Table 1. Peritoneal dialysis training tools for allied health care professionals
Meetings with peritoneal dialysis courses available for allied health care professionals:
International Society for Peritoneal Dialysis North American Chapter meeting every other year
National Kidney Foundation spring meeting every year
ASN pre-meeting course
Annual Dialysis Conference
Online peritoneal dialysis course: freely available at ispd.org (http://ispd.org/NAC/education/
pd-curriculum/)
Journal: Peritoneal Dialysis International: free online after first year, free to members of the ISPD.
Maximizing Success with Peritoneal Dialysis: Best
Demonstrated Practices
By Seth B. Furgeson and Isaac Teitelbaum
P
eritoneal dialysis offers unique advantages for patients
with ESRD. Peritoneal dialysis offers the convenience of home dialysis, allows continuous solute and fluid
removal, and, for the incident dialysis patient, appears to
be less harmful to residual kidney function (RKF). Many
peritoneal dialysis patients have successfully used the therapy for a decade or longer without significant problems. To
maximize success with peritoneal dialysis, providers must
carefully attend to its many components. Preserving RKF,
maintaining peritoneal membrane function, preventing
cardiovascular disease, and avoiding infectious complications are all crucial components of therapy.
Preserving residual kidney function
It has long been recognized that peritoneal dialysis is associated with a slower decline in RKF than hemodialysis.
Studies have also demonstrated that preservation of RKF
correlates with improved survival. RKF allows for increased
volume removal as well as improved phosphorus and middle molecule clearance. To preserve RKF, providers need to
minimize nephrotoxic medications (e.g., intravenous contrast medium, nonsteroidal anti-inflammatory drugs), avoid
rapid fluid shifts and hypovolemia, and, whenever possible,
treat with blockers of the renin-angiotensin system. Two
small randomized trials have shown that angiotensin converting enzyme inhibitors and angiotensin receptor block-
ers can minimize the loss in RKF (1,2). It is therefore recommended that patients with RKF receive either of these
agents, assuming there are no contraindications.
Maintaining peritoneal membrane function
For peritoneal dialysis to be successful, adequate ultrafiltration is essential. However, in many peritoneal dialysis
patients, anatomical changes in the peritoneal membrane
affect ultrafiltration. Currently, a leading hypothesis posits that prolonged exposure over time to bioincompatible
peritoneal solutions (high glucose, high glucose degradation products, low pH) damages mesothelial cells lining
the peritoneum and increases vascularity of the peritoneum.
August 2012 | ASN Kidney News |
Consequently, over time, many patients will have more
rapid solute transport, quicker dissipation of the glucoseinduced osmotic gradient, and less ultrafiltration. Given
the available data, it seems prudent to minimize glucose
exposure during dwells. Furthermore, salt restriction and
judicious use of diuretics can reduce the need for hypertonic solutions. Recently, more biocompatible solutions
(normal pH or low glucose degradation products) have
been studied in small trials. To date, however, these trials
have not conclusively determined whether biocompatible
solutions preserve peritoneal membrane function, and
their routine use cannot yet be recommended. Further
data are necessary.
In some patients, atherosclerotic coronary disease contributes to the increased risk of cardiac death. The SHARP
study, a trial comparing ezetimibe/simvastatin with placebo in chronic kidney disease and dialysis patients, enrolled 496 patients in peritoneal dialysis. Although there
was a trend toward reduced atherosclerotic events in the
treatment group, it was not statistically significant (3).
By contrast, observational U.S. Renal Data System data
from Dialysis Morbidity and Mortality Study wave 2 do
indicate a significant decrease in both all-cause and cardiovascular mortality in peritoneal dialysis patients using
lipid-lowering therapy (4). We routinely treat our peritoneal dialysis patients with lipid-lowering therapy targeting low-density lipoprotein <100 mg/dL.
Preventing cardiovascular disease
Avoiding infectious complications
As is true of patients receiving hemodialysis, cardiovascular disease is the primary cause of death in peritoneal
dialysis patients. The majority of patients beginning dialysis have evidence of left ventricular hypertrophy (LVH)
that correlates with an increased risk of sudden cardiac
death. Hypertension and chronic volume overload likely
contribute to LVH. Randomized controlled trials comparing a daily icodextrin dwell with a dextrose dwell have
shown improved ultrafiltration and LVH. Peritoneal dialysis providers must use a comprehensive care plan to
help patients remain euvolemic. Dietary sodium restriction, diuretics, and icodextrin (in appropriate patients)
are all components of this care plan.
Both peritonitis and refractory infections of the exit site
or tunnel are associated with significant morbidity. Catheter loss, ultrafiltration failure, and death are all associated with peritonitis. To minimize the risk for peritonitis,
proper patient training and sterile technique are essential. Controlled trials have also shown that local antibiotic prophylaxis at exit sites, such as gentamicin cream or
mupirocin, can reduce the risk of peritonitis and should
therefore be routinely used.
In conclusion, peritoneal dialysis is a well-tolerated
treatment for ESRD patients. Paying attention to these
aspects of therapy will maximize the chances of successful
peritoneal dialysis.
15
Seth B. Furgeson and Isaac Teitelbaum are with the division of
renal diseases and hypertension at the University of Colorado
Anschutz Medical Campus in Aurora, CO, and Seth Furgeson is with the renal division at Denver Health Hospital.
References
1. Li PK, Chow KM, Wong TY, et al. Effects of an
angiotensin-converting enzyme inhibitor on residual
renal function in patients receiving peritoneal dialysis. A randomized, controlled study. Ann Intern Med
2003: 139: 105–112.
2. Suzuki H, Kanno Y, Sugahara S, Okada H, et al. Effects of an angiotensin II receptor blocker, valsartan,
on residual renal function in patients on CAPD. Am
J Kidney Dis 2004; 43: 1056–1064.
3. Baigent C, Landray MJ, Reith C, et al. The effects
of lowering LDL cholesterol with simvastatin plus
ezetimibe in patients with chronic kidney disease
(Study of Heart and Renal Protection): a randomised
placebo-controlled trial. Lancet 2011, 377:21812192.
4. Goldfarb-Rumyantzev AS, Habib AN, Bair BC, et al.
The association of lipid-modifying medications with
mortality in patients on long-term peritoneal dialysis. American journal of kidney diseases : the official
journal of the National Kidney Foundation 2007; 50:
791–802.
Getting the Right Care at the Right Time: Empowering
Patients with Effective CKD Modality Education
By Leanna B. Tyshler and Mary Dooley
M
ost new dialysis patients start dialysis without permanent access and unaware of home therapies.
Making informed decisions and starting with a permanent access are strongly associated with patients getting the right care at the right time. Northwest Kidney
Centers, a nonprofit dialysis provider, has made a significant commitment to predialysis modality education. We
educate about 300 patients per year, plus their families and
friends. About 30 percent of our incident dialysis patients
have attended our classes before starting renal replacement
therapy. The focus is simple: help patients consider home
therapies and renal transplantation, and start dialysis with
a permanent access.
3
These are some elements essential to effective education:
1 The primary responsibility of program educators
is education about chronic kidney disease (CKD).
We have a dedicated CKD nurse and a social
worker who are knowledgeable and passionate
about modality education.
2 Program structure is flexible, is widely available,
and provides the right amount of information.
Scheduling and location should not be barriers for
patients. We offer Choices, a 2.5-hour class that
gives an overview of treatment options, four times
a month, each at a different location in our service
area. We see patients individually when education
is needed urgently, if an interpreter is required, or
if concerns need to be discussed privately. We use
a phased model for education because every patient needs to know the basics, but some may need
more information. After attending the Choices
overview class, a patient can attend “graduate
school”—shorter classes focused on one modality
(peritoneal dialysis, home hemodialysis, or trans-
posters in offices, reminders in our publications
directed to nephrologists, reminders at meetings,
and informal contacts from our staff and from the
highest level in the organization. We look for a
nephrologist “champion” in every group, and we
partner with office staff to facilitate the referral
process. After we receive referrals from nephrologists, we make several attempts to reach patients
and to track those who refuse treatment or are unreachable. With aggressive follow-up on all referrals, 80 to 90 percent of referred patients attend
our classes.
plantation). These “next step” classes provide more
in-depth information and emphasize treatment
planning.
4
The right curriculum is key. We have developed a
curriculum that is understandable, is relatable, and
facilitates informed consent based on three principles:
• Health literacy: The CKD population and the
low health literacy population overlap. We
use standardized PowerPoint materials with
minimal words, many pictures, and stories.
All handouts are written at a 5th to 6th grade
reading level.
• Patient-centered: The choice of a dialysis modality is a psychosocial one, made in the context of personal goals and lifestyle. To make
education relevant, we try to understand the
patient’s personal situation rather than simply
present information.
• Evidence-based: Educating for informed consent means presenting understandable and
compelling facts on survival, risks, and benefits.
CKD patients must be reached at the right time.
The KDOQI guidelines state that every patient
with stage 4 disease should receive modality education. Dialysis providers have access to CKD
patients only through nephrologists’ referrals.
Marketing to nephrologists is essential to create a
culture in which referral to modality education is
routine and expected. We emphasize the value to
the nephrologist of having an educated patient—
better patient compliance, better outcomes, and
time saved in the office. We provide literature and
5
Continuing communication with nephrologists is
a must. We keep the referring nephrologists in the
loop at every step. We report whether a patient
attends, summarize the patient’s modality preference, and discuss any barriers. Feedback underscores the credibility and effectiveness of our program. We give nephrologists “report cards” that
show how many of their patients attended class,
how many new patients started peritoneal dialysis,
and how many started hemodialysis with permanent access. Every report reiterates outcomes data
that support the efficacy of our program: Attendees are 2.5 times more likely to choose peritoneal
dialysis and 44 percent more likely to start hemodialysis with a permanent access in place and in
use.
6
The immediate goal of education is not education—it is action. Patients may leave class planning on peritoneal dialysis but then start later with
in-center hemodialysis. To address this, we retooled the Choices curriculum to focus on coachContinued on page 16
The List: ASN Kidney
News “What
to Watch” in 2011
Peritoneal
Dialysis
CKD Modality Education
Continued from page 15
ing patients to take the next step, priming patients
to go back to their nephrologist with specific questions (“Am I a candidate for peritoneal dialysis?”
“When should I get a peritoneal dialysis access?”)
and to actively plan (e.g., plan for peritoneal dialysis at work and figure out home supply storage).
We are also piloting a patient navigation program for
Choices attendees who are interested in home dialysis that
includes routine telephone contacts with the CKD nurse
educator, who provides guidance toward treatment goals.
The right care at the right time benefits patients, nephrologists, and dialysis providers. Timely and effective
modality education empowers patients to take actions
that improve their health and quality of life. But it takes
significant and thoughtful institutional commitment to
make a program successful. We believe that the impact on
the long-term quality outcomes of our organization makes
it a worthwhile investment.
Suggested Reading
1. United States Renal Data System 2011.
2. Mehrota R, Marsh D, Vonesh E, et al. Patient education and access of ESRD patients to renal replacement
therapies beyond in-center hemodialysis. Kidney Int
2005; 68:378–390.
3. Leibman SE, Bushinsky DA, Dolan JG, et al. Differences between dialysis modality selection and initiation. Am J Kidney Dis 2012; 59:550–557.
Leanna B. Tyshler, MD, and Mary Dooley, MSW, are affiliated with Northwest Kidney Centers in Seattle, WA.
Historical Reasons for Underuse
of Peritoneal Dialysis in the
United States
By Gregory L. Braden
I
mprovements in the delivery of peritoneal dialysis in the 1980s using plastic dialysate bags rather than bottles, Y-sets for continuous ambulatory
peritoneal dialysis, improved catheter design, and
the development of easy-to-use automated peritoneal dialysis cyclers have made peritoneal dialysis
an effective option to treat patients with ESRD. In
addition, the peritoneal membrane removed toxic
“middle molecules” better than earlier-generation
hemodialysis filters made with cupraphan. In the
1980s, in our center and in some dialysis centers in the United States, up to 35 percent of all
ESRD patients were receiving peritoneal dialysis,
but this percentage has recently dropped to under
10 percent. The use of peritoneal dialysis in the
United States lags far behind that of other countries. Several reasons may explain the underuse of
peritoneal dialysis in the United States.
Over the past two decades, U.S. physicians have
developed a bias against and lack of enthusiasm
for peritoneal dialysis. Early studies suggested
that the mortality of peritoneal dialysis patients
was greater than that of similar patients receiving hemodialysis, and even recent studies suggest
that the mortality of peritoneal dialysis patients
older than 45 years may be greater than that in
similar patients on hemodialysis. These studies
may have biased some nephrologists against offering peritoneal dialysis to their patients. However,
newer registry and epidemiologic studies in the
United States, Canada, and Denmark have shown
that mortality is lower with peritoneal dialysis in
the early years of therapy compared with similar
patients receiving hemodialysis. When these data
are taken together, there is no clear evidence that
survival is better in ESRD patients with hemodialysis than in those receiving peritoneal dialysis.
Thus, any apparent survival difference is not great
enough between modalities to warrant physicians
offering either method over the other for patients
approaching ESRD. Rather, psychosocial issues,
complex medical problems, and patient choice
should determine who can successfully perform
peritoneal dialysis.
Physicians’ bias favoring hemodialysis over peritoneal dialysis may also be due to recent improvements in biocompatible hemodialyzers, which
now have better middle molecule clearance. In ad-
dition, the rise of interventional
radiologists placing temporary
or longer-term dialysis catheters
allows easier management of the
initial uremic state with hemodialysis. Annually, approximately 15
percent of patients receiving peritoneal dialysis transfer to hemodialysis
because of severe peritonitis, peritoneal membrane failure, or catheter malfunction. Difficulty in achieving dialysis
adequacy in patients with a large body mass
index and insufficient training of nephrology
fellows in the management of peritoneal dialysis
patients are additional reasons why nephrologists
have shifted away from peritoneal dialysis as an
important therapy for ESRD.
In the past two decades, most academic centers that train nephrology fellows no longer provide peritoneal dialysis education and training in
their hospital-owned peritoneal dialysis programs.
Rather, hospitals have divested their nonprofitable
dialysis units to one of several national dialysis
companies that primarily focus on hemodialysis
patients, with few resources or champions devoted
to peritoneal dialysis. However, the new bundled
payment schedule for ESRD patients offered by
the Centers for Medicare and Medicaid Services
financially favors the use of peritoneal dialysis
and should help increase the numbers of ESRD
patients receiving it. The ease and focus on hemodialysis rather than on peritoneal dialysis has
diminished the use of the latter. However, developing the expertise of physicians and nurses could
enhance the use of peritoneal dialysis as an effective therapy for ESRD.
Suggested Reading
1. Bloembergen WE, Port FK, Mauger EA, et al.
A comparison of cause of death between patients treated with hemodialysis and peritoneal
dialysis. J Am Soc Nephrol 1995; 6:184–191.
2. Vonesh EF, Moran J. Mortality in end-stage
renal disease: a reassessment of difference between patients treated with hemodialysis and
peritoneal dialysis. J Am Soc Nephrol 1999;
10:354–365.
3. Stack AG, Molony DA, Rahman NS, et al. Im-
4.
5.
6.
7.
8.
9.
pact of dialysis modality on survival of new
ESRD patients with congestive heart failure in
the United States. Kidney Int 2003; 64:1071–
1079.
Ganesh SK, Hulbert-Shearon T, Port FK, et
al. Mortality difference by dialysis modality
among incident ESRD patients with and without coronary artery disease. J Am Soc Nephrol
2003; 14:415–424.
Vonesh EF, Snyder JJ, Foley RN, et al. Mortality studies comparing peritoneal dialysis and
hemodialysis: what do they tell us? Kidney Int
2006, 70:S3–S11.
Murphy SW, Foley RN, Barrett BJ, et al. Comparative mortality of hemodialysis and peritoneal dialysis in Canada. Kidney Int 2000;
57:1720–1726.
Mehrotra R, Kermah D, Fried L, et al. Chronic
peritoneal dialysis in the United States: declining utilization despite improving outcomes. J
Am Soc Nephrol 2007; 18:2781–2788.
Mehrotra R, Chiu Y, Kalantar-Zadeh K, et al.
Similar outcomes with hemodialysis and peritoneal dialysis in patients with end-stage renal
disease. Arch Intern Med 2011; 171:110–118.
Blake PG, Suri RS. Peritoneal dialysis vs. hemodialysis: time to end the debate? Nat Rev
Nephrol 201; 7:308–310.
Gregory L. Braden, MD, is fellowship director and
chief of the nephrolog y division at Baystate Medical Center/Tufts University School of Medicine in
Spring field, MA.
August 2012 | ASN Kidney News |
17
Implications of Regulatory and Reimbursement
Changes for the Future Success of Peritoneal Dialysis
By Suzanne Watnick
P
atients with ESRD constitute less than 1 percent
of the total Medicare population but account for
nearly 7 percent of dollars spent. Recognizing powerful
financial incentives for the overuse of certain separately billable items, Congress mandated that the Centers
for Medicare and Medicaid Services implement a perdialysis-session expanded bundled payment in 2008.
This bundled payment aims to reduce costs, attempting
to pay no more than dialysis providers require to offer
high-quality care. Any change in profit margin would be
recognized by the dialysis provider; thus, the drive to do
less as opposed to more might be incentivized by such a
payment system. Also, dialysis modalities that cost less
than others would be encouraged. The costs of peritoneal dialysis, not including payments to physicians, are
estimated to be approximately $20,000 lower than the
costs of hemodialysis, with similar outcomes noted between modalities over the first several years of therapy.
A major implication of these regulatory and reimbursement changes is the expansion of peritoneal dialysis use, reversing the trend over the past 20 years. The
use of peritoneal dialysis in the United States peaked at
16 percent in 1985 and started to decline around 1994
to the current prevalence rate of 7 to 8 percent. Data
showing a possible reversal of the downward trend will
be forthcoming in a General Accounting Office report
due in March 2013. U.S. Renal Data System data for
2011 have not yet been released, and the full impact of
these changes may not be understood until well after
2012.
If the use of peritoneal dialysis grows, peritoneal dialysis units may receive additional resources, which may
drive additional growth. Economies of scale may decrease
costs even further. With a more comprehensive bundled
payment system, dialysis providers have already shifted
some of their resources to promote peritoneal dialysis as
an underused modality. Even before the reimbursement
changes, large dialysis organizations recognized the ben-
efit of having an expanded home dialysis program.
Another relevant regulatory change was the addition
of the Medicare education benefit in January 2010. Providers are now reimbursed for up to six sessions to educate patients with stage 4 chronic kidney disease about
dialysis options, which may drive an increased use of
peritoneal dialysis. In one study of 1600 ESRD patients
surveyed, of the 61 percent who were counseled about all
dialysis options, 11 percent started peritoneal dialysis. Of
the 39 percent not counseled, only 1.6 percent started
peritoneal dialysis.
With further resources and more education benefits,
providers may have a greater percentage of their patients
begin with peritoneal dialysis rather than with hemodialysis. More patients who are less fit as candidates for
peritoneal dialysis may be swayed to start it. Interestingly,
this may increase the expense of peritoneal dialysis and
narrow the gap between the expenses of one dialysis modality versus another.
Last, with these regulatory and reimbursement changes and the potential increase in use of peritoneal dialysis,
the workforce needs to be prepared to care for these patients. Better provider education may expand the use of
peritoneal dialysis. Studies have shown that nephrology
fellowship trainees have much less exposure than their
Canadian counterparts and than historical control individuals, given the decreased use of peritoneal dialysis in
this country. Groups such as the International Society of
Peritoneal Dialysis and the American Society of Nephrology have recognized this and have made concerted efforts
to create and sponsor additional educational experiences,
such as a peritoneal dialysis curriculum and focus groups
among the directors of nephrology fellowship training
programs.
In this changing practice environment, many opportunities exist to expand peritoneal dialysis. As a community we should promote these changes in the most
thoughtful way to provide care for our patients, who
cannot always advocate for themselves. Through active
education of patients and providers, close communication with policy makers and dialysis providers, and conscientious monitoring of the effects of these changes, we
can encourage the optimal provision of peritoneal dialysis
in this country.
Suggested Reading
1. Collins AJ, Foley RN, Herzog C, et al. U.S. Renal
Data System 2010 Annual Data Report. Am J Kidney
Dis 2011; 57(1 Suppl 1):A8, e1–526.
2. Medicare program; end-stage renal disease prospective payment system. Final rule. Fed Regist 2010;
75:49029–49214.
3. Mehrotra R, Chiu YW, Kalantar-Zadeh K, et al.
Similar outcomes with hemodialysis and peritoneal
dialysis in patients with end-stage renal disease. Arch
Intern Med 2011; 171:110–118.
4. Kutner NG, Zhang R, Huang Y, et al. Patient awareness and initiation of peritoneal dialysis. Arch Intern
Med 2011; 171:119–124
5. Johansen KL. Choice of dialysis modality in the United States. Arch Intern Med 2011; 171:107–109.
6. Jain A, Blake P, Cordy P, et al. Global trends in
rates of peritoneal dialysis. J Am Soc Nephrol 2012;
23:533–544.
7. Pulliam J, Hakim R, Lazarus M. Peritoneal dialysis in
large chains. Perit Dial Int 2006; 26:435–437.
8. Berns JS. A survey-based evaluation of self-perceived
competency after nephrology fellowship training.
Clin J Am Soc Nephrol 2010; 5:490–496.
9. Mehrotra R, Blake P, Berman N, et al. An analysis of
dialysis training in the United States and Canada. Am
J Kidney Dis 2002; 40:152–160.
Suzanne Watnick, MD, is associate professor of medicine
and fellowship program director at the Oregon Health and
Science University in Portland, OR.
Available Now
ASN Highlights Online:
the latest advances in kidney care and research
ASN Highlights Online provides CME credit for over 8 hours of state-of-the-art
presentations on:
· Acute Kidney Injury
· End-Stage Renal Disease
· Kidney Transplantation
· Parenchymal Disorders
· Hypertension
· Clinical Nephrology
Online Learning | The ASN Advantage
www.asn-online.org/learningcenter
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18
| ASN Kidney News | August 2012
Policy Update
CMS Proposes Revisions to ESRD Payment
System, Additions to Quality Incentive Program
By Rachel Shaffer
T
he Centers for Medicare and
Medicaid Services (CMS) released
a proposed rule on July 2, 2012, that
addresses dialysis care. The ASN Quality Metrics Task Force is analyzing the
proposed rule and, with the ASN Public Policy Board, will provide input to
CMS on behalf of ASN members.
The proposed rule updates Medicare’s dialysis payment system administered through the End-Stage Renal
Disease (ESRD) Prospective Payment
System (PPS). The Prospective Payment System pays a predetermined,
fixed amount for all services related
to each dialysis treatment. This is also
known as a “bundled” payment system.
The Quality Incentive Program
(QIP) is the first-ever mandatory value-based purchasing program within
the Medicare system. Under the QIP,
facilities that do not meet or exceed
performance standards on quality
measures receive a reduction in their
payment rates. The QIP operates concurrently with the ESRD PPS.
After Congress mandated the
ESRD PPS and QIP in 2008, approximately 90 percent of dialysis providers
elected to begin receiving all payments
under the new, bundled payment system from year one.
The proposed changes released for
public comment on July 2 would affect
dialysis treatments provided during
calendar year 2013, while changes to
the ESRD QIP would affect payments
to providers in 2015 and beyond. Payment reductions would be calculated
based on data from dialysis treatments
provided beginning in 2013. In addition, the proposed rule describes a
proposal to implement changes to bad
debt reimbursement to eligible Medicare providers.
Table 1. Proposed criteria for considering removal or
replacement of quality measures
1. Measure performance among the majority of ESRD facilities is so high and
unvarying that meaningful distinctions in improvements or performance can no
longer be made.
2. Performance or improvement on a measure does not result in better or the
intended patient outcomes.
3. A measure no longer aligns with current clinical guidelines or practice.
How would the proposed rule
change the ESRD PPS?
4. A more broadly applicable (across settings, populations, or conditions) measure
for the topic becomes available.
The ESRD PPS base rate set for 2012
was $234.81; CMS proposes to increases this rate to $240.88 per dialysis
treatment in calendar year 2013. On
the basis of price factors and a projected
increase in Medicare dialysis beneficiary enrollment, CMS estimates that dialysis facilities in 2013 will collect approximately $8.7 billion for treatments
in 2013, a 3.1 percent overall increase.
CMS notes that this increased payment
to dialysis facilities means beneficiaries
will also likely see a 3.1 percent increase
in their co-payment responsibility.
Providers who opted to receive
transitional “blended payments” will
collect reimbursement that is 25 percent based on the previous composite
payment system, and 75 percent based
on the new PPS payment system.
Jonathan Blum, CMS deputy administrator and director of the agency’s Center for Medicare, believes “that
the policies and rate changes proposed
today will continue to help ensure that
beneficiaries diagnosed with ESRD
continue to get the care they need.”
5. A measure that is more proximal in time to desired patient outcomes for the
particular topic becomes available.
6. A measure that is more strongly associated with desired patient outcomes for
the particular topic becomes available.
7. Collection or public reporting of a measure leads to negative unintended
consequences.
Table 2. Proposed 2015 clinical and reporting quality measures
QIP measures under consideration by CMS
1. Standardized Hospitalization Ratio (NQF #1463)
2. Dialysis Facility Risk-Adjusted Standardized Mortality Ratio
(NQF # 0369)
3. 30-Day Hospitalization Readmission Measure related to care
coordination
4. Efficiency measure (though CMS states it is not aware of an
efficiency measure appropriate for the ESRD population)
5. Population/community health measure (CMS requests comments
on developing such a measure)
Aspect of care
evaluated
Measure
New Measure?
Anemia
management
1. Percentage of Medicare patients with a
hemoglobin >12 g/dL (clinical)
Existing
2. Anemia Management: Report hemoglobin or
hematocrit level and ESA dose, if applicable, for
98 percent of patients (reporting)
New
3. Kt/V measure for adult hemodialysis patients
(clinical)
New (replace
URR measure)
Dialysis adequacy
4. Kt/V measure for adult hemodialysis patients
(clinical)
5. Kt/V measure for pediatric hemodialysis
patients (clinical)
Vascular access type
6. Percentage of Medicare hemodialysis patients
using an autogenous AV fistula with two needles
during the last HD treatment of the month; and
7. Percentage of Medicare hemodialysis patients
who have an intravenous catheter in place for
90 days or longer prior to the last hemodialysis
session.
Existing
Bone mineral
metabolism
management
8. Hypercalcemia: Medicare patients with
uncorrected serum calcium concentration
>10.2 mg/dL (clinical)
New
9. Mineral metabolism: Medicare patients serum
calcium and serum phosphorus levels on
monthly basis (reporting)
Existing
(expanded)
Patient Safety
10.National Healthcare Safety Network (NHSN)
Dialysis Event Reporting: Reports dialysis
infection events to the Centers for Disease
Control and Prevention on monthly basis
(reporting)
Existing
(expanded)
Patient Satisfaction
11.Patient Experience of Care Survey Usage:
Surveys patients using in-center hemodialysis
(ICH) consumer assessment of health care
providers and systems (CAHPS) about
experience of care
Existing
Table 3. Timeline of proposed comparison, performance, and payment periods 2011–2015
2011
Comparison Period
CMS collects national
performance data;
uses data to calculate
benchmarks,
thresholds in 2015
2013
2015
Performance period
CMS collects facility
data on quality
measures
Payment Year
CMS applies payment
reductions in 2015
based on facilities’
2013 performance
versus benchmarks,
thresholds
August 2012 | ASN Kidney News |
How would the proposed rule
change the ESRD QIP?
The most significant proposed changes
would apply to the ESRD QIP starting
in 2015. CMS proposes adopting new
clinical and reporting measures, as well
as expanding the scope of two current reporting measures. These changes reflect a
broader range of issues faced by patients
who receive dialysis care.
CMS also puts forth criteria for removing or replacing quality measures.
Finalized quality measures would remain part of the QIP program unless
CMS alters or eliminates them through
rulemaking or notification. However, if
CMS believes a measure raises potential
safety concerns, it proposes to immediately remove the measure from the QIP
instead of waiting for the annual rulemaking cycle. The proposed criteria are
summarized in Table 1.
Altogether, CMS recommends a total
of 11 quality measures in 2015. These
are summarized in Table 2. Among the
new measures, CMS proposes to institute a reporting-only anemia management measure. Dialysis facilities would
be required to report hemoglobin or
hematocrit levels and erythropoiesisstimulating agent (ESA) dose, if applicable, for 98 percent of patients. CMS
“monitoring activities indicate that there
has been a slight but noticeable increase
in transfusions since the adoption of the
ESRD PPS” and references a May 2012
United States Renal Data System analysis that found an increase in transfusions
among ESRD patients concurrent with
PPS implementation. Data collected
from the proposed measure would facilitate development of future quality measures in an area “of critical significance to
patient safety—anemia and transfusion”
states CMS.
If the changes in the proposed rule
are finalized, the 2015 QIP would apply new measures of dialysis adequacy
to different patient populations—including adult peritoneal dialysis patients
and pediatric hemodialysis patients.
The proposed National Quality Forum
(NQF)-endorsed measures would assess
whether patients meet a modality-specific Kt/V threshold, and would replace the
current urea reduction ratio measure of
dialysis adequacy.
In addition, CMS proposes to add
a clinical hypercalcemia measure (ex-
amining patient-months of Medicare
patients with uncorrected serum calcium concentration >10.2 mg/dL) and
expand the existing mineral metabolism
measure by requiring facilities to report
a serum calcium and serum phosphorus
for every qualifying patient-month. The
expanded reporting measure would allow CMS to develop mineral metabolism measures based on clinical data in
the future.
Looking ahead, CMS is soliciting
comments on measures it is considering adopting for future years of the QIP.
These measures are summarized in the
sidebar.
Proposed QIP scoring and
evaluation
CMS proposes using the same scoring
methodology for clinical measures in
payment year 2015 as it used in payment
year 2014 QIP, assessing providers on
both “achievement” and “improvement”
scales. As in 2014, CMS would score
providers in payment year 2015 along
an achievement scale ranging from an
achievement threshold (set at the 15th
percentile of the national facility per-
19
formance in 2011) to the benchmark (set
at the 90th percentile of the national facility performance in 2011).
The improvement scale would range
from the improvement threshold (the providers’ own performance on each measure in 2012) to the same benchmark.
CMS would again calculate payments
using whichever scale the facility scores
better on, achievement or improvement.
CMS proposes to establish calendar
year 2013 as the performance period for
all of the payment year 2015 measures.
To ensure time to calculate standards
for payment year 2015, CMS proposes
calendar year 2011 as the “comparison
period” using national performance data
from that time to calculate the achievement threshold and benchmarks in payment year 2015 (Table 3). However,
CMS requests input on this issue since
stakeholders might prefer standards
based on more recent data, despite limitations, and requests input.
CMS is accepting public comment
regarding the proposed rule until Friday,
August 31, 2012. For a complete copy
of the proposed rule as well as other resources, please visit the ASN public policy website at www.asn-online.org.
Industry Spotlight
DaVita Settles Federal Claim
D
aVita recently settled a
whistle-blower lawsuit from
2002 regarding its anemia
management practices with a $55
million payment but no admission of
wrongdoing by the company.
According to Zacks Financials, an
online investment news website, Denver-based DaVita has adequate funds
for the settlement, with cash and cash
equivalents totaling $449 million as of
March 31, 2012. The stock remained
unaffected after the announcement,
Zacks reported. However, the financial
website did note that in October 2011
two law firms had begun investigating
DaVita because of alleged over-billing
of Medicare by the company, and if
such charges were found to be valid
they could weigh on the company’s financials.
In DaVita’s announcement of the
settlement the company stated that
“DaVita and its affiliated physicians
did nothing wrong and stand by their
anemia management practices, which
were always consistent with their mission of providing the best possible care
for each individual patient. As a result,
the agreement contains no finding of
wrongdoing or admission of liability
by DaVita or its affiliated physicians.”
To explain why the company decided to settle with the individual who
sued, DaVita said that “agreements
such as this one are sometimes in the
best interest of shareholders.”
The government investigated allegations raised by a sole individual in
Texas regarding the company’s Epogen practices over a 10-year period.
During that time, DaVita stated “the
government never intervened or filed
any claims against DaVita. However,
the individual was able to pursue the
claims on his own.”
In the fall of 2011 Amgen said it had
set aside $780 million for potential settlements in whistle-blower lawsuits and
investigations of its marketing practices
for Epogen and its other anemia medi-
cations, according to October 2011
coverage in the Denver Post, which follows DaVita news in depth.
The Medicare ESRD prospective
payment system—which pays a bundled sum for all services given to a
patient rather than reimbursement
for individual drug doses, for example—began January 1, 2011. This new
system has reduced profits attached to
individual orders of Epogen and other
drugs.
“Critics of the Medicare payment
system argued for years that paying dialysis providers for every unit of Epogen used encouraged overuse of the
drug,” the Denver Post reported.
Index to Advertisers
DaVita . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Back Cover
Takeda Pharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pages 7-9
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